A Phase 2 interventional study of CP-690,550 Eye drops and CP-690,550 Eye drops in Dry Eye Syndromes, sponsored by Pfizer. Completed at 27 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-05-07.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 285 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: CP-690,550 Eye drops
Drug: CP-690,550 Eye drops
Drug: CP-690,550 Eye drops
Drug: CP-690,550 Eye drops-vehicle
Drug: Sodium Hyaluronate
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
Ophthalmic topical solution, dosed 6 times/day, 8 weeks
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 8
Changes in Corneal Staining Scores for Study Eye From Baseline
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2 and 4
Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 \[Absent\] to 5 \[Severe\]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Changes in the Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[the none of time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 1 to 3 answered) × 100\]/\[(total number of questions 1 to 3 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 4 to 9 answered) × 100\]/\[(total number of questions 4 to 9 answered) × 4\]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 10 to 12 answered) × 100\]/\[(total number of questions 10 to 12 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
Time frame: Baseline, Week 1, 2, 4 and 8
Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 1, 2, 4 and 8
Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 8
Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 8
Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 8
Number of Participants With Ocular Adverse Events (AEs)by Severity
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: 8 weeks
Number of Participants With Nonocular Adverse Events (AEs) by Severity
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: 8 weeks
Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: 8 weeks
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye
The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye
Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4
Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
Time frame: Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
Time frame: Baseline, Week 4 and 8
| Milestone | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Started | 41 | 42 | 41 | 40 | 39 | 21 | 19 | 21 | 21 |
| Completed | 41 | 39 | 33 | 37 | 38 | 20 | 18 | 20 | 20 |
| Not completed | 0 | 3 | 8 | 3 | 1 | 1 | 1 | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Could not visit the clinic | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Noncompliance with study drug taken | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8 | -3.0 ± 2.1 | -3.0 ± 2.8 | -3.0 ± 2.5 | -3.1 ± 2.6 | -3.2 ± 2.4 | -2.4 ± 2.4 | -3.0 ± 2.7 | -2.8 ± 1.9 | -2.2 ± 2.5 |
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 | -2.1 ± 1.9 | -1.9 ± 2.1 | -1.9 ± 2.1 | -1.6 ± 2.0 | -2.0 ± 2.0 |
| Week 2 | -2.4 ± 1.8 | -2.4 ± 2.0 | -3.2 ± 1.8 | -3.0 ± 2.0 | -2.8 ± 2.1 |
| Week 4 | -2.7 ± 2.0 | -3.0 ± 2.7 | -3.2 ± 2.4 | -3.3 ± 2.5 | -2.6 ± 2.1 |
Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Percentage of participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 4.9 | 2.4 | 5.0 | 0 | 0 |
| Week 2 (n=40, 41, 39, 40, 39) | 2.5 | 2.4 | 5.1 | 7.5 | 2.6 |
| Week 4 (n=41, 40, 35, 40, 38) | 12.2 | 5.0 | 8.6 | 7.5 | 2.6 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | 12.2 | 4.9 | 7.5 | 7.5 | 0 |
Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 \[Absent\] to 5 \[Severe\]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | -0.8 ± 1.9 | -0.7 ± 1.8 | -0.6 ± 1.3 | -1.1 ± 1.7 | -0.6 ± 1.7 |
| Week 2 (n=40, 41, 39, 40, 39) | -1.0 ± 2.2 | -0.8 ± 2.0 | -0.7 ± 1.5 | -1.7 ± 2.5 | -1.0 ± 2.1 |
| Week 4 (n=41, 40, 35, 40, 38) | -1.2 ± 2.2 | -1.0 ± 1.7 | -0.8 ± 1.5 | -2.0 ± 2.4 | -1.1 ± 2.2 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | -1.0 ± 2.3 | -1.1 ± 2.1 | -0.9 ± 1.4 | -2.0 ± 2.1 | -0.9 ± 1.8 |
TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
| Seconds | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 0.04 ± 0.83 | 0.43 ± 3.61 | 0.19 ± 0.76 | 0.22 ± 1.95 | 0.43 ± 3.22 |
| Week 2 (n=40, 41, 39, 40, 39) | 0.09 ± 0.95 | -0.31 ± 2.84 | 0.26 ± 0.84 | 0.04 ± 1.54 | 1.72 ± 8.53 |
| Week 4 (n=41, 40, 35, 40, 38) | -0.01 ± 0.92 | 0.20 ± 3.61 | 0.31 ± 0.62 | 0.46 ± 1.87 | 0.53 ± 1.42 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | -0.06 ± 1.13 | -0.25 ± 2.17 | 0.27 ± 0.77 | 1.00 ± 3.56 | 0.76 ± 1.38 |
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.
| Millimeters | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 0.78 ± 6.07 | 0.34 ± 3.10 | 0.01 ± 2.16 | 0.08 ± 3.01 | 0.71 ± 3.99 |
| Week 2 (n=40, 41, 39, 40, 39) | 0.28 ± 2.77 | 0.51 ± 3.49 | 0.28 ± 2.26 | 0.93 ± 3.56 | 1.04 ± 4.53 |
| Week 4 (n=41, 40, 35, 40, 38) | 0.30 ± 3.39 | 0.49 ± 2.54 | 0.13 ± 2.28 | 1.13 ± 4.23 | 0.64 ± 3.38 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | 0.91 ± 5.43 | 0.10 ± 2.57 | 0.74 ± 2.46 | 0.26 ± 2.93 | 1.53 ± 5.32 |
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Percentage of participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 7.3 | 4.9 | 0 | 2.5 | 7.7 |
| Week 2 (n=40, 41, 39, 40, 39) | 2.5 | 4.9 | 2.6 | 7.5 | 10.3 |
| Week 4 (n=41, 40, 35, 40, 38) | 7.3 | 5.0 | 2.9 | 7.5 | 5.3 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | 9.8 | 4.9 | 2.5 | 5.0 | 12.8 |
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 2 | 1 | 0 | 1 | 1 |
| Week 2 (n=40, 41, 39, 40, 39) | 0 | 1 | 0 | 2 | 2 |
| Week 4 (n=41, 40, 35, 40, 38) | 1 | 0 | 0 | 2 | 1 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | 3 | 0 | 0 | 1 | 3 |
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | -1.94 ± 5.20 | -2.00 ± 6.22 | -2.13 ± 7.92 | -4.17 ± 6.86 | -3.14 ± 7.88 |
| Week 2 (n=40, 41, 40, 40, 39) | -4.16 ± 9.00 | -4.76 ± 7.63 | -3.80 ± 8.77 | -5.88 ± 6.98 | -3.40 ± 6.12 |
| Week 4 (n=41, 40, 35, 40, 38) | -3.27 ± 6.95 | -4.20 ± 7.08 | -5.77 ± 9.71 | -5.74 ± 7.26 | -3.58 ± 9.85 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | -5.09 ± 7.74 | -4.98 ± 7.67 | -3.90 ± 9.30 | -6.87 ± 8.59 | -4.22 ± 9.53 |
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 17 | 15 | 13 | 21 | 16 |
| Week 2 (n=40, 41, 40, 40, 39) | 19 | 21 | 19 | 28 | 20 |
| Week 4 (n=41, 40, 35, 40, 38) | 23 | 23 | 21 | 26 | 16 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | 25 | 26 | 22 | 26 | 16 |
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | -0.43 ± 12.33 | -3.87 ± 12.42 | -0.67 ± 12.68 | -5.00 ± 9.13 | -2.99 ± 10.27 |
| Week 2 (n=40, 41, 40, 40, 39) | -4.09 ± 13.73 | -7.04 ± 12.98 | -3.13 ± 14.45 | -6.77 ± 11.28 | -2.89 ± 11.34 |
| Week 4 (n=41, 40, 35, 40, 38) | -3.18 ± 13.77 | -5.99 ± 15.78 | -4.48 ± 13.92 | -5.11 ± 14.03 | -2.56 ± 12.69 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | -3.88 ± 14.92 | -7.07 ± 17.88 | -0.37 ± 16.77 | -5.89 ± 14.98 | -2.68 ± 15.10 |
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[the none of time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 1 to 3 answered) × 100\]/\[(total number of questions 1 to 3 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | -0.81 ± 15.90 | -4.07 ± 13.83 | -3.96 ± 13.74 | -5.00 ± 12.77 | -2.56 ± 14.70 |
| Week 2 (n=40, 41, 40, 40, 39) | -4.17 ± 19.61 | -8.74 ± 18.06 | -3.75 ± 14.24 | -7.92 ± 16.01 | -3.63 ± 13.49 |
| Week 4 (n=41, 40, 35, 40, 38) | -3.05 ± 18.89 | -7.50 ± 19.59 | -6.19 ± 14.05 | -5.42 ± 17.56 | -1.97 ± 15.43 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | -3.86 ± 19.01 | -7.72 ± 21.20 | -2.29 ± 17.29 | -6.04 ± 18.87 | -0.21 ± 15.59 |
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 4 to 9 answered) × 100\]/\[(total number of questions 4 to 9 answered) × 4\]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | -0.36 ± 18.75 | -4.71 ± 14.31 | 0.40 ± 17.35 | -6.55 ± 12.20 | -3.33 ± 13.41 |
| Week 2 (n=40, 41, 40, 40, 39) | -2.61 ± 16.88 | -5.83 ± 15.52 | -2.29 ± 20.91 | -7.06 ± 11.87 | -2.57 ± 14.48 |
| Week 4 (n=41, 40, 35, 40, 38) | -1.70 ± 16.73 | -6.52 ± 15.25 | -4.74 ± 17.82 | -4.29 ± 14.04 | -2.69 ± 15.35 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | -2.56 ± 19.45 | -8.29 ± 16.61 | -2.07 ± 18.71 | -4.75 ± 12.49 | -3.81 ± 17.46 |
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for questions 10 to 12 answered) × 100\]/\[(total number of questions 10 to 12 answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
| Units on a scale | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=38, 37, 40, 39, 35) | 1.21 ± 22.11 | -4.28 ± 23.66 | 0.31 ± 22.20 | -3.53 ± 15.52 | -4.88 ± 20.32 |
| Week 2 (n=37, 37, 39, 37, 37) | -6.53 ± 20.43 | -7.21 ± 25.43 | -6.20 ± 22.25 | -8.56 ± 18.66 | -4.28 ± 21.48 |
| Week 4 (n=38, 37, 35, 37, 36) | -6.14 ± 23.72 | -3.15 ± 30.23 | -2.14 ± 24.88 | -9.57 ± 22.78 | -4.17 ± 23.44 |
| Week 8 (n=38, 37, 40, 39, 38, LOCF) | -7.13 ± 22.92 | -4.05 ± 34.11 | 3.02 ± 31.76 | -8.44 ± 27.83 | -4.82 ± 24.46 |
The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the OSDI questionnaire were graded on a scale of 0 \[none of the time\] to 4 \[all of the time\]. The total OSDI score was then calculated on the basis of the following formula: OSDI=\[(sum of scores for all questions answered) × 100\]/\[(total number of questions answered) × 4\]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Percentage of participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 1 (n=41, 41, 40, 40, 39) | 14.6 | 24.4 | 12.5 | 22.5 | 20.5 |
| Week 2 (n=40, 41, 40, 40, 39) | 32.5 | 34.1 | 27.5 | 25.0 | 20.5 |
| Week 4 (n=41, 40, 35, 40, 38) | 34.1 | 37.5 | 25.7 | 35.0 | 18.4 |
| Week 8 (n=41, 41, 40, 40, 39, LOCF) | 34.1 | 41.5 | 22.5 | 35.0 | 20.5 |
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining. 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye | 8 | 4 | 6 | 5 | 1 |
The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye | 8 | 6 | 2 | 4 | 7 |
The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 \[Never\] to 6 \[Always\], or 0 \[Never had it\] to 6 \[Severe\]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores | 31 | 29 | 30 | 35 | 28 |
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Mild | 4 | 0 | 4 | 2 | 2 | 3 | 7 | 0 | 6 |
| Moderate | 0 | 0 | 1 | 0 | 0 | 2 | 3 | 6 | 4 |
| Severe | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 2 | 0 |
Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Mild | 7 | 12 | 10 | 10 | 8 | 2 | 1 | 5 | 4 |
| Moderate | 1 | 0 | 2 | 0 | 0 | 3 | 1 | 4 | 2 |
| Severe | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| None for blurring of vision | 32 | 33 | 32 | 32 | 36 | 11 | 11 | 15 | 13 |
| Minor for blurring of vision | 9 | 8 | 7 | 8 | 3 | 9 | 6 | 5 | 7 |
| Moderate for blurring of vision | 0 | 1 | 2 | 0 | 0 | 1 | 2 | 1 | 1 |
| Severe for blurring of vision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| None for burning sensation | 26 | 22 | 26 | 27 | 34 | 7 | 7 | 11 | 9 |
| Minor for burning sensation | 15 | 19 | 14 | 12 | 4 | 10 | 10 | 9 | 10 |
| Moderate for burning sensation | 0 | 0 | 1 | 1 | 0 | 3 | 2 | 1 | 2 |
| Severe for burning sensation | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| None for ocular discomfort | 30 | 29 | 30 | 31 | 29 | 6 | 4 | 7 | 6 |
| Minor for ocular discomfort | 10 | 12 | 9 | 8 | 8 | 8 | 11 | 6 | 8 |
| Moderate for ocular discomfort | 1 | 1 | 2 | 1 | 1 | 6 | 3 | 7 | 6 |
| Severe for ocular discomfort | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 |
| None for pain | 28 | 30 | 34 | 32 | 34 | 12 | 9 | 12 | 9 |
| Minor for pain | 13 | 11 | 6 | 7 | 3 | 4 | 10 | 7 | 9 |
| Moderate for pain | 0 | 0 | 1 | 1 | 2 | 4 | 0 | 2 | 3 |
| Severe for pain | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| None for tearing | 40 | 38 | 39 | 37 | 36 | 15 | 15 | 18 | 19 |
| Minor for tearing | 1 | 3 | 2 | 3 | 3 | 6 | 4 | 3 | 2 |
| Moderate for tearing | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe for tearing | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC). Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change = value at observation minus value at baseline.
| Antibodies bound per cell | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=7, 4, 9, 12, 8) | 1570.4 ± 8698.5 | -13899.5 ± 13383.8 | 5394.3 ± 10641.9 | 1573.8 ± 10087.5 | -1908.6 ± 11259.4 |
| Week 8 (n=6, 4, 6, 11, 10) | -1496.5 ± 10426.5 | -8326.3 ± 11164.6 | 56.0 ± 5308.4 | 3431.9 ± 16532.5 | 1148.5 ± 12129.6 |
Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Percentage of positive cells | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=7, 4, 9, 12, 8) | -10.27 ± 20.73 | -0.87 ± 18.24 | 11.51 ± 18.74 | -6.83 ± 28.64 | 18.30 ± 30.40 |
| Week 8 (n=6, 4, 6, 11, 10) | -6.77 ± 18.19 | 6.65 ± 25.65 | 5.17 ± 24.73 | -1.05 ± 35.75 | 11.74 ± 24.84 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| ng/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -30.675 ± 78.363 | -38.540 ± 93.153 | -153.500 ± 164.756 | -6384.063 ± 12606.637 | 58.500 ± 59.729 |
| Week 8 (n=4, 6, 2, 5, 3) | -39.250 ± 786.061 | -5.167 ± 33.983 | -70.800 ± 16.688 | -5102.010 ± 11352.752 | -1.300 ± 1.752 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 247.5 ± 374.7 | -73.0 ± 57.6 | 146.0 ± 206.5 | -154.6 ± 287.3 | 22.5 ± 57.1 |
| Week 8 (n=4, 6, 2, 5, 3) | -81.3 ± 110.7 | -6.0 ± 186.1 | 100.0 ± 43.8 | 18.0 ± 210.9 | 51.2 ± 27.0 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 76.00 ± 140.92 | -36.80 ± 48.75 | 22.50 ± 21.92 | -19.70 ± 126.34 | 16.33 ± 34.70 |
| Week 8 (n=4, 6, 2, 5, 3) | -11.00 ± 23.35 | 4.00 ± 25.49 | 139.00 ± 192.33 | 25.80 ± 141.39 | 12.00 ± 14.00 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 35.8 ± 51.6 | -6.8 ± 38.8 | 28.0 ± 22.6 | 3.5 ± 73.6 | 10.0 ± 50.7 |
| Week 8 (n=4, 6, 2, 5, 3) | 14.3 ± 16.7 | 19.5 ± 30.9 | -15.0 ± 8.5 | -16.4 ± 28.6 | 25.0 ± 16.5 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 365.0 ± 348.2 | -18.8 ± 739.1 | -7.0 ± 470.9 | -1057.3 ± 1954.2 | 564.3 ± 1171.8 |
| Week 8 (n=4, 6, 2, 5, 3) | -2486.3 ± 4656.3 | -367.8 ± 961.9 | -112.5 ± 484.4 | -471.6 ± 2378.4 | 305.7 ± 361.9 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -168.5 ± 265.3 | -438.8 ± 962.4 | 24.5 ± 79.9 | -468.0 ± 390.6 | 26.7 ± 63.1 |
| Week 8 (n=4, 6, 2, 5, 3) | -179.3 ± 144.1 | -289.7 ± 1205.3 | -169.5 ± 217.1 | 28.2 ± 431.0 | -14.3 ± 33.9 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -5.0 ± 16.1 | -5.4 ± 17.0 | 27.0 ± 14.1 | -17.0 ± 24.9 | 3.7 ± 22.7 |
| Week 8 (n=4, 6, 2, 5, 3) | 17.5 ± 21.7 | 15.8 ± 57.9 | 0.0 ± 0.0 | 1.6 ± 38.4 | 31.7 ± 23.6 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -0.05 ± 1.60 | -1.42 ± 5.22 | 2.75 ± 0.35 | -4.93 ± 10.29 | 6.03 ± 8.54 |
| Week 8 (n=4, 6, 2, 5, 3) | -0.70 ± 4.97 | -0.42 ± 5.84 | 6.00 ± 8.49 | -2.14 ± 7.88 | 2.03 ± 0.15 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=3, 5, 2, 4, 3) | 76500.0 ± 363953.6 | -172800.0 ± 256165.4 | 269500.0 ± 498510.3 | -370575.0 ± 647507.1 | 15600.0 ± 156124.6 |
| Week 8 (n=4, 6, 2, 5, 2) | -256000.0 ± 451986.0 | 153833.3 ± 317150.7 | 200000.0 ± 144249.8 | -268260.0 ± 546901.3 | 397550.0 ± 621476.1 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| ng/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 3.15 ± 6.14 | -13.80 ± 22.14 | 8.00 ± 21.21 | -7.13 ± 19.21 | 2.73 ± 3.04 |
| Week 8 (n=4, 6, 2, 5, 3) | -6.78 ± 18.62 | 3.60 ± 16.65 | -4.00 ± 9.90 | 0.60 ± 6.02 | 0.00 ± 0.00 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| ng/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 2.675 ± 5.952 | -1.948 ± 3.682 | -0.470 ± 1.598 | -24.833 ± 48.019 | 0.957 ± 1.202 |
| Week 8 (n=4, 6, 2, 5, 3) | 21.205 ± 42.696 | -0.517 ± 3.527 | -0.650 ± 0.919 | -14.476 ± 31.070 | 0.203 ± 0.313 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| ng/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 22.3 ± 35.8 | -13.2 ± 29.5 | 8.5 ± 12.0 | -88.3 ± 120.8 | 35.0 ± 60.6 |
| Week 8 (n=4, 6, 2, 5, 3) | 0.0 ± 0.0 | 57.0 ± 90.1 | 37.5 ± 53.0 | -41.2 ± 46.7 | 26.7 ± 69.0 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 152.5 ± 1620.5 | -942.0 ± 2466.2 | 840.0 ± 735.4 | -1486.5 ± 4486.5 | 546.7 ± 546.4 |
| Week 8 (n=4, 6, 2, 5, 3) | -1812.5 ± 1477.6 | 790.0 ± 1639.2 | -910.0 ± 2588.0 | 734.0 ± 3267.6 | -699.3 ± 1094.8 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| ng/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -1115.0 ± 3226.2 | -4054.0 ± 8558.2 | 1535.0 ± 2170.8 | -628.5 ± 5314.7 | 5400.0 ± 3104.5 |
| Week 8 (n=4, 6, 2, 5, 3) | -2902.5 ± 4534.4 | 505.0 ± 2977.2 | -1375.0 ± 1944.5 | 1220.8 ± 4111.8 | 2246.7 ± 2329.9 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 1.98 ± 5.47 | -2.08 ± 4.28 | 1.95 ± 2.76 | -4.30 ± 9.40 | 1.60 ± 1.44 |
| Week 8 (n=4, 6, 2, 5, 3) | -1.18 ± 1.39 | 0.88 ± 4.75 | 0.00 ± 0.00 | -3.58 ± 8.01 | 3.93 ± 4.61 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=3, 5, 2, 4, 3) | -1196.7 ± 3885.1 | -7224.0 ± 27315.6 | 14545.0 ± 24967.9 | -11622.5 ± 28687.6 | 15103.3 ± 56584.3 |
| Week 8 (n=4, 6, 2, 5, 2) | -13440.0 ± 27749.2 | 18971.7 ± 30883.3 | -6230.0 ± 7028.6 | 6306.0 ± 24845.5 | -9690.0 ± 13732.0 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=3, 4, 2, 4, 3) | -633.3 ± 1325.5 | -47485.0 ± 110811.6 | 21025.0 ± 45078.1 | -18020.0 ± 44942.7 | 14003.3 ± 22925.3 |
| Week 8 (n=4, 5, 2, 5, 2) | -34722.5 ± 62344.4 | 3118.0 ± 23681.2 | -10150.0 ± 2899.1 | 22148.0 ± 36704.1 | -4220.0 ± 5741.7 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 1.3 ± 541.7 | 47.4 ± 281.2 | 630.0 ± 325.3 | -1562.5 ± 2787.4 | -301.3 ± 1138.3 |
| Week 8 (n=4, 6, 2, 5, 3) | -1237.8 ± 1975.3 | 534.5 ± 868.9 | -360.0 ± 1004.1 | -327.6 ± 2083.1 | 246.7 ± 331.6 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 13.25 ± 31.28 | -12.06 ± 70.14 | 21.50 ± 40.31 | -28.98 ± 57.50 | 19.43 ± 51.60 |
| Week 8 (n=4, 6, 2, 5, 3) | -61.48 ± 79.46 | -3.83 ± 81.17 | 6.50 ± 36.06 | -9.58 ± 49.45 | -8.93 ± 15.77 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| ng/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 12.5 ± 85.9 | -19.8 ± 73.5 | 124.5 ± 173.2 | -131.8 ± 165.9 | 142.3 ± 375.9 |
| Week 8 (n=4, 6, 2, 5, 3) | -48.5 ± 69.8 | 34.3 ± 75.2 | -109.0 ± 168.3 | -76.8 ± 88.1 | 114.0 ± 167.7 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| pg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -0.5 ± 495.3 | -213.2 ± 1803.5 | -138.5 ± 186.0 | 0.5 ± 3816.2 | -121.7 ± 1815.2 |
| Week 8 (n=4, 6, 2, 5, 3) | -15.5 ± 370.2 | 361.0 ± 857.7 | -885.0 ± 1322.3 | -122.0 ± 1612.5 | -212.7 ± 532.5 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| mcg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -228.00 ± 409.55 | -28.20 ± 94.15 | 42.50 ± 181.73 | 111.75 ± 293.07 | 164.67 ± 73.04 |
| Week 8 (n=4, 6, 2, 5, 3) | 99.50 ± 354.15 | 125.17 ± 292.09 | 1.00 ± 147.08 | 96.00 ± 141.26 | 81.33 ± 75.63 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| Relative unit/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=3, 5, 2, 4, 3) | 1704.00 ± 4222.07 | -871.40 ± 4857.15 | 383.00 ± 24.04 | -35221.50 ± 67264.76 | 1651.67 ± 7544.36 |
| Week 8 (n=4, 6, 2, 5, 3) | -18222.00 ± 32490.62 | 487.83 ± 5164.47 | 6926.00 ± 10004.15 | -35105.40 ± 84919.27 | -1698.33 ± 2346.05 |
Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.
| Participants | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 | 2 | 2 | 1 | 1 | 1 |
| Week 8 | 0 | 2 | 1 | 1 | 1 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| Relative unit/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 44.8 ± 337.3 | -228.6 ± 1493.7 | -41.0 ± 312.5 | -648.5 ± 1710.9 | 130.0 ± 178.0 |
| Week 8 (n=4, 6, 2, 5, 3) | -487.3 ± 364.0 | 4.0 ± 910.5 | 265.5 ± 685.2 | -427.6 ± 1479.9 | -289.3 ± 86.8 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| Relative unit/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 41.0 ± 35.6 | 194.8 ± 428.5 | 79.5 ± 89.8 | -328.5 ± 634.9 | -5.3 ± 23.5 |
| Week 8 (n=4, 6, 2, 5, 3) | -97.0 ± 183.0 | 33.5 ± 124.2 | 30.5 ± 57.3 | -80.2 ± 200.1 | -15.3 ± 23.2 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| mcg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | -17.00 ± 2539.88 | 257.00 ± 382.18 | -3115.50 ± 4418.71 | -651.00 ± 659.50 | 573.00 ± 8434.01 |
| Week 8 (n=4, 6, 2, 5, 3) | -1524.50 ± 2083.82 | 588.67 ± 1504.14 | -3560.00 ± 5048.74 | 222.60 ± 1420.46 | -417.00 ± 4540.91 |
Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change= value at visit minus value at baseline.
| mcg/mL | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan |
|---|---|---|---|---|---|
| Week 4 (n=4, 5, 2, 4, 3) | 748.8 ± 4116.3 | -956.0 ± 4190.6 | 1180.0 ± 311.1 | -8281.3 ± 13425.6 | 6328.3 ± 17461.8 |
| Week 8 (n=4, 6, 2, 5, 3) | -2322.5 ± 4827.1 | 836.7 ± 4104.5 | -5695.0 ± 8605.5 | -3070.0 ± 4798.4 | 5195.0 ± 9724.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CP-690,550 Eye Drops Vehicle Group in Japan | — | 0/41 (0%) | 11/41 (26.8%) |
| CP-690,550 Eye Drops 0.001% Group in Japan | — | 0/42 (0%) | 11/42 (26.2%) |
| CP-690,550 Eye Drops 0.003% Group in Japan | — | 2/41 (4.9%) | 16/41 (39%) |
| CP-690,550 Eye Drops 0.005% Group in Japan | — | 0/40 (0%) | 8/40 (20%) |
| Sodium Hyaluronate Eye Drops 0.1% Group in Japan | — | 0/39 (0%) | 9/39 (23.1%) |
| CP-690,550 Eye Drops Vehicle Group in Korea | — | 0/21 (0%) | 6/21 (28.6%) |
| CP-690,550 Eye Drops 0.001% Group in Korea | — | 0/19 (0%) | 7/19 (36.8%) |
| CP-690,550 Eye Drops 0.003% Group in Korea | — | 1/21 (4.8%) | 6/21 (28.6%) |
| CP-690,550 Eye Drops 0.005% Group in Korea | — | 0/21 (0%) | 8/21 (38.1%) |
| Event | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| BronchiectasisInfections and infestations | 0/41 | 0/42 | 0/41 | 0/40 | 0/39 | 0/21 | 0/19 | 1/21 | 0/21 |
| Gastric ulcerGastrointestinal disorders | 0/41 | 0/42 | 1/41 | 0/40 | 0/39 | 0/21 | 0/19 | 0/21 | 0/21 |
| Foot fractureInjury, poisoning and procedural complications | 0/41 | 0/42 | 1/41 | 0/40 | 0/39 | 0/21 | 0/19 | 0/21 | 0/21 |
| Event | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea |
|---|---|---|---|---|---|---|---|---|---|
| Eye irritationEye disorders | 0/41 | 0/42 | 0/41 | 0/40 | 0/39 | 3/21 | 3/19 | 2/21 | 2/21 |
| NasopharyngitisInfections and infestations | 2/41 | 4/42 | 2/41 | 5/40 | 1/39 | 1/21 | 0/19 | 0/21 | 0/21 |
| Vision blurredEye disorders | 0/41 | 0/42 | 1/41 | 0/40 | 0/39 | 1/21 | 2/19 | 1/21 | 0/21 |
| KeratitisEye disorders | 1/41 | 0/42 | 1/41 | 0/40 | 0/39 | 0/21 | 0/19 | 2/21 | 0/21 |
| Optic nerve cup/disc ratio increasedInvestigations | 0/41 | 0/42 | 0/41 | 0/40 | 0/39 | 0/21 | 0/19 | 0/21 | 2/21 |
| White blood cells urine positiveInvestigations | 0/41 | 0/42 | 0/41 | 0/40 | 3/39 | 0/21 | 0/19 | 0/21 | 0/21 |
| Conjunctival haemorrhageEye disorders | 1/41 | 0/42 | 0/41 | 0/40 | 0/39 | 0/21 | 1/19 | 0/21 | 0/21 |
| Eye painEye disorders | 0/41 | 0/42 | 0/41 | 0/40 | 1/39 | 0/21 | 1/19 | 1/21 | 1/21 |
| Meibomian gland dysfunctionEye disorders | 0/41 | 0/42 | 0/41 | 0/40 | 0/39 | 0/21 | 1/19 | 0/21 | 0/21 |
| Ocular discomfortEye disorders | 0/41 | 0/42 | 1/41 | 0/40 | 0/39 | 0/21 | 1/19 | 1/21 | 1/21 |
| Age, Customized(participants) | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Between 18 and 44 years | 14 | 14 | 11 | 11 | 11 | 5 | 8 | 7 | 3 | 84 |
| Between 45 and 64 years | 9 | 14 | 12 | 16 | 14 | 10 | 8 | 13 | 10 | 106 |
| >=65 years | 18 | 14 | 18 | 13 | 14 | 6 | 3 | 1 | 8 | 95 |
| Sex: Female, Male(Participants) | CP-690,550 Eye Drops Vehicle Group in Japan | CP-690,550 Eye Drops 0.001% Group in Japan | CP-690,550 Eye Drops 0.003% Group in Japan | CP-690,550 Eye Drops 0.005% Group in Japan | Sodium Hyaluronate Eye Drops 0.1% Group in Japan | CP-690,550 Eye Drops Vehicle Group in Korea | CP-690,550 Eye Drops 0.001% Group in Korea | CP-690,550 Eye Drops 0.003% Group in Korea | CP-690,550 Eye Drops 0.005% Group in Korea | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 32 | 39 | 37 | 33 | 34 | 20 | 16 | 20 | 19 | 250 |
| Male | 9 | 3 | 4 | 7 | 5 | 1 | 3 | 1 | 2 | 35 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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