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CompletedNCT00784719Updated Apr 9, 2013Results posted

A Prospective, Randomized, Placebo and Active Comparator Controlled Study of CP-690,550 in Subjects With Dry Eye.

A Phase 1/2 interventional study of CP-690,550 and CP-690,550 in Dry Eye Syndromes, sponsored by Pfizer. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-09.

Sponsored by Pfizer · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
327
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.

02

Conditions studied

  • Dry Eye Syndromes

Keywords

  • Dry eye
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 327 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Symptoms of dry eye for at least 6 months.
  • Signs of moderate to severe dry eye

Exclusion criteria

Exclusion Criteria:

  • Women who are nursing or pregnant
  • Participation in other studies within 30 days of screening visit
  • Ocular disorders that may confound interpretation of study results
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
327 participants (actual)

Study arms

  • Experimental
    Treatment 1

    Drug: CP-690,550

  • Experimental
    Treatment 2

    Drug: CP-690,550

  • Experimental
    Treatment 3

    Drug: CP-690,550

  • Experimental
    Treatment 4

    Drug: CP-690,550

  • Active comparator
    Active comparator

    Drug: Cyclosporine

  • Placebo comparator
    Placebo

    Drug: CP-690,550 Vehicle

Interventions

  • DrugCP-690,550

    Ophthalmic topical solution, low dose, dosed at least once/day, 8 weeks

  • DrugCP-690,550

    Ophthalmic topical solution, medium dose, dosed at least once/day, 8 weeks

  • DrugCP-690,550

    Ophthalmic topical solution, intermediate dose, dosed at least once/day, 8 weeks

  • DrugCP-690,550

    Ophthalmic topical solution, high dose, dosed at least once/day, 8 weeks

  • DrugCyclosporine

    Ophthalmic topical solution, 0.05%, dosed at least once/day, 8 weeks

  • DrugCP-690,550 Vehicle

    Ophthalmic topical solution, dosed at least once/day, 8 weeks

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Systemic Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.

    Time frame: Baseline up to Week 8

  2. Percentage of Participants With Ocular Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.

    Time frame: Baseline up to Week 8

  3. Percentage of Participants With Ocular Tolerability Assessment

    Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).

    Time frame: Baseline up to Week 8

  4. Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8

    Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Week 8

Secondary outcomes

  1. Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia

    Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline through Week 8

  2. Time to Achieve 100 Percent (%) Clearance of Corneal Staining

    Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline through Week 8

  3. Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score

    OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.

    Time frame: Baseline through Week 8

  4. Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8

    Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  5. Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8

    Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline, Week 8

  6. Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6

    Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Week 1, 2, 4, 6

  7. Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8

    Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Week 8

  8. Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8

    Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  9. Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining

    Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Week 1, 2, 4, 6, 8

  10. Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8

    Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  11. Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8

    TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  12. Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8

    OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  13. Percentage of Participants With >= 5 Units Decrease in Total OCI Score

    OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.

    Time frame: Week 1, 2, 4, 6, 8

  14. Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8

    Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  15. Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8

    OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 \[Q1\]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  16. Percentage of Participants With >= 10 Units Decrease in Total OSDI Score

    OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.

    Time frame: Week 1, 2, 4, 6, 8

  17. Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8

    OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  18. Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8

    mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.

    Time frame: Baseline, Week 1, 2, 4, 6, 8

  19. Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8

    NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.

    Time frame: Baseline, Week 8

07

Results

Posted Apr 9, 2013
Limitations and caveats
In this study, a variance was made in the planned analysis. At the time of data analysis, results from Stage 1 and 2 were combined for efficacy and safety analyses. Hence, results are presented together for both stages.

Participant flow

Participant flow — Overall Study
MilestonePlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Started47464748484447
Completed44434648424142
Not completed3310635
Withdrew: Adverse event0200111
Withdrew: Lost to follow-up0000110
Withdrew: Other2110213
Withdrew: Withdrawal by subject1000201

Outcome measures

PrimaryPercentage of Participants With Systemic Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.

Time frame:
Baseline up to Week 8
Reported as:
Number · percentage of participants
Percentage of Participants With Systemic Adverse Events (AEs)
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Percentage of Participants With Systemic Adverse Events (AEs)27.78.729.827.118.818.223.4
PrimaryPercentage of Participants With Ocular Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.

Time frame:
Baseline up to Week 8
Reported as:
Number · percentage of participants
Percentage of Participants With Ocular Adverse Events (AEs)
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Percentage of Participants With Ocular Adverse Events (AEs)25.521.731.922.922.922.736.2
PrimaryPercentage of Participants With Ocular Tolerability Assessment

Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).

Time frame:
Baseline up to Week 8
Reported as:
Number · percentage of participants
Percentage of Participants With Ocular Tolerability Assessment
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Ocular discomfort:none55.650.053.252.146.869.834.1
Ocular discomfort:mild33.328.325.529.244.718.634.1
Ocular discomfort:moderate11.119.619.114.68.59.325.0
Ocular discomfort:severe0.02.22.14.20.02.36.8
Ocular discomfort:moderate/severe, duration>=5 min4.410.98.510.44.37.022.7
Burning sensation:none26.743.523.433.329.832.618.2
Burning sensation:mild55.639.159.639.653.248.840.9
Burning sensation:moderate17.815.214.922.914.916.336.4
Burning sensation:severe0.02.22.14.22.12.34.5
Burning sensation:moderate/severe,duration>=5 min0.02.22.10.04.34.711.4
Pain:none82.280.480.985.485.188.461.4
Pain:mild13.310.98.56.312.87.025.0
Pain:moderate4.46.56.46.32.12.39.1
Pain:severe0.02.24.32.10.02.34.5
Pain:moderate/severe, duration >=5 min2.20.00.00.00.00.00.0
Tearing:none55.663.068.172.966.069.847.7
Tearing:mild40.026.121.316.729.811.629.5
Tearing:moderate4.410.910.610.44.318.611.4
Tearing:severe0.00.00.00.00.00.011.4
Tearing:moderate/severe, duration >= 5 min0.02.26.42.10.04.76.8
Blurred vision:none51.154.353.258.351.144.236.4
Blurred vision:mild40.030.434.027.136.234.940.9
Blurred vision:moderate6.715.212.88.38.518.620.5
Blurred vision:severe2.00.00.06.34.32.32.3
Blurred vision:moderate/severe, duration >=5 min0.02.24.34.26.47.02.3
PrimaryPercentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8

Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 820.017.825.518.826.127.335.6
SecondaryTime to Achieve >= 10mm Schirmer Test Score Without Anesthesia

Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline through Week 8
Reported as:
Median · days
Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia
daysPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Time to Achieve >= 10mm Schirmer Test Score Without AnesthesiaNA (NA to NA)NA (NA to NA)59.00 (NA to NA)58.00 (NA to NA)NA (NA to NA)57.00 (NA to NA)NA (NA to NA)
Statistical analysis
  • CP-690,550, 0.001% Twice Daily · Median: 59.00
  • CP-690,550, 0.003% Twice Daily · Median: 58.00
  • CP-690,550, 0.005% Once Daily · Median: 57.00
SecondaryTime to Achieve 100 Percent (%) Clearance of Corneal Staining

Corneal staining was assessed by instilling sodium fluorescein dye in the eye and after 1 to 2 minutes, observing for corneal staining with the aid of a yellow filter and slit lamp. The cornea was divided into five different zones and each corneal zone was graded independently using a 0 to 3 grading scale; where 0=none, 1=slight, 2=moderate, 3=severe. Results from study eye were to be reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline through Week 8
Reported as:
Median · days
Time to Achieve 100 Percent (%) Clearance of Corneal Staining
daysPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Time to Achieve 100 Percent (%) Clearance of Corneal StainingNA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
SecondaryTime to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score

OCI: validated questionnaire to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contained 12 questions, each measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.

Time frame:
Baseline through Week 8
Reported as:
Median · days
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score
daysPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score15.00 (NA to NA)8.50 (NA to NA)15.00 (NA to NA)9.50 (NA to NA)9.00 (NA to NA)15.00 (NA to NA)16.00 (NA to NA)
Statistical analysis
  • Placebo Twice Daily · Median: 15.00 · 80% CI 9.0 to 28.0
  • CP-690,550, 0.0003% Twice Daily · Median: 8.50 · 80% CI 8.0 to 27.0
  • CP-690,550, 0.001% Twice Daily · Median: 15.00 · 80% CI 15.0 to 27.0
  • CP-690,550, 0.003% Twice Daily · Median: 9.50 · 80% CI 8.0 to 15.0
  • CP-690,550, 0.005% Twice Daily · Median: 9.00 · 80% CI 8.0 to 15.0
  • CP-690,550, 0.005% Once Daily · Median: 15.00 · 80% CI 8.0 to 43.0
  • Restasis Twice Daily · Median: 16.00 · 80% CI 15.0 to 30.0
SecondaryChange From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8

Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · mm
Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8
mmPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,44,47)4.15 ± 2.074.40 ± 2.204.02 ± 2.123.77 ± 1.874.43 ± 2.294.40 ± 2.244.74 ± 2.03
Change at Week 1 (n=45,45,47,47,44,42,43)2.06 ± 4.541.68 ± 4.690.80 ± 3.032.07 ± 3.871.80 ± 4.642.68 ± 6.113.60 ± 5.44
Change at Week 2 (n=44,46,46,48,45,44,44)2.43 ± 4.981.63 ± 4.042.67 ± 4.443.13 ± 4.612.74 ± 4.603.43 ± 6.623.84 ± 5.66
Change at Week 4 (n=44,43,45,48,44,39,43)2.42 ± 6.642.69 ± 4.562.56 ± 4.761.72 ± 3.601.66 ± 5.034.21 ± 7.034.06 ± 6.65
Change at Week 6 (n=43,44,43,47,42,41,43)1.86 ± 3.821.41 ± 3.271.59 ± 3.551.76 ± 4.113.64 ± 6.574.65 ± 6.303.87 ± 5.75
Change at Week 8 (n=45,46,47,48,47,44,45)1.89 ± 5.222.30 ± 4.732.19 ± 4.223.59 ± 6.222.60 ± 4.803.76 ± 6.284.48 ± 7.05
SecondaryChange From Baseline in Schirmer Wetting Score With Anesthesia at Week 8

Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline, Week 8
Reported as:
Mean · mm
Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8
mmPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,43,47)6.56 ± 4.697.58 ± 4.446.63 ± 5.056.67 ± 4.017.85 ± 5.357.92 ± 5.138.14 ± 5.75
Change at Week 8 (n=43,43,45,48,41,39,42)2.24 ± 5.070.13 ± 5.472.56 ± 6.111.48 ± 5.48-0.44 ± 5.130.83 ± 6.041.74 ± 5.74
SecondaryPercentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6

Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Week 1, 2, 4, 6
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Week 120.09.16.414.911.616.730.2
Week 218.220.023.916.725.022.736.4
Week 418.220.917.810.416.328.230.2
Week 620.99.116.312.834.139.034.9
SecondaryPercentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8

Schirmer test was performed 2 to 3 minutes after 1 drop of proparacaine 0.5% was placed in lower conjunctival fornix and superior bulbar conjunctiva of each eye. It was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 mm. If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 832.627.948.931.324.425.638.1
SecondaryChange From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8

Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · units on a scale
Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8
units on a scalePlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,44,47)6.64 ± 3.455.63 ± 1.955.83 ± 2.106.73 ± 2.946.21 ± 2.546.36 ± 2.716.85 ± 3.50
Change at Week 1 (n=45,45,47,47,44,42,44)-1.16 ± 2.39-0.89 ± 2.05-0.87 ± 2.25-1.32 ± 2.58-0.20 ± 1.95-1.17 ± 2.510.02 ± 3.27
Change at Week 2 (n=44,46,46,48,45,44,44)-1.02 ± 3.16-1.15 ± 2.33-1.00 ± 2.19-1.98 ± 2.50-0.91 ± 2.26-1.52 ± 2.73-0.61 ± 2.94
Change at Week 4 (n=44,43,45,48,44,39,43)-2.48 ± 2.53-1.02 ± 2.58-1.33 ± 2.69-1.40 ± 2.54-0.82 ± 2.45-2.10 ± 2.31-1.00 ± 2.86
Change at Week 6 (n=43,44,43,48,42,41,43)-2.21 ± 3.49-1.39 ± 2.50-1.21 ± 2.42-1.75 ± 3.06-1.31 ± 3.00-2.27 ± 2.69-1.49 ± 3.03
Change at Week 8 (n=45,46,47,48,47,44,45)-2.67 ± 3.44-1.39 ± 2.92-1.28 ± 2.65-1.58 ± 3.04-1.47 ± 2.73-2.64 ± 2.94-1.18 ± 3.50
SecondaryPercentage of Participants Who Demonstrated 100% Clearance of Corneal Staining

Corneal staining was assessed using fluorescein dye, yellow filter, slit lamp. Cornea was divided into 5 different zones. Each corneal zone was graded independently using 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. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Week 1, 2, 4, 6, 8
Reported as:
Number · percentage of participants
Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Week 12.20.00.00.00.04.80.0
Week 22.34.30.04.20.04.50.0
Week 44.52.34.46.32.32.64.7
Week 64.76.87.04.27.17.37.0
Week 86.76.54.310.46.415.94.5
SecondaryChange From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8

Interpalpebral conjunctival staining was performed 1 minute following ocular administration of lissamine green dye with aid of slit lamp. Based on Oxford grading system, bulbar conjunctiva was divided into 2 zones: nasal, temporal. Staining were graded using a 6-point scale (0=absent, 5=severe). Total score=sum of 2 zone scores. Total score range: 0 to 10, higher score=higher damage to eyes due to dryness. Negative change from baseline indicated improvement. Results from study eye are reported. Study eye is the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · units on a scale
Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8
units on a scalePlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,43,47)2.77 ± 2.362.17 ± 1.432.21 ± 1.812.38 ± 2.082.17 ± 1.991.91 ± 1.662.43 ± 2.03
Change at Week 1 (n=45,45,47,47,44,42,43)-0.44 ± 1.52-0.38 ± 1.76-0.34 ± 1.75-0.13 ± 2.06-0.45 ± 1.420.17 ± 1.50-0.09 ± 1.92
Change at Week 2 (n=44,46,46,48,45,43,44)-0.89 ± 1.53-0.26 ± 1.41-0.37 ± 1.44-0.29 ± 1.57-0.44 ± 1.62-0.19 ± 1.380.05 ± 2.47
Change at Week 4 (n=44,43,45,48,44,39,43)-1.11 ± 1.86-0.53 ± 1.65-0.60 ± 1.56-0.27 ± 1.87-0.11 ± 1.370.18 ± 1.35-0.07 ± 1.64
Change at Week 6 (n=43,44,43,48,42,41,43)-0.84 ± 1.38-0.73 ± 1.63-0.44 ± 1.74-0.46 ± 1.68-0.12 ± 1.710.02 ± 1.98-0.14 ± 1.90
Change at Week 8 (n=45,46,47,48,47,43,45)-0.82 ± 2.01-0.57 ± 1.78-0.62 ± 1.81-0.63 ± 1.71-0.13 ± 1.78-0.14 ± 1.82-0.18 ± 1.57
SecondaryChange From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8

TBUT was the time interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. It was measured under a slit lamp following instillation of fluorescein dye in the eye using a stopwatch. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · seconds
Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8
secondsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,43,47)3.50 ± 1.323.96 ± 3.304.32 ± 2.744.65 ± 6.504.12 ± 2.443.90 ± 2.473.95 ± 2.30
Change at Week 1 (n=45,45,47,47,44,42,44)0.17 ± 1.630.60 ± 2.110.21 ± 2.50-0.27 ± 1.55-0.07 ± 1.26-0.51 ± 2.24-0.14 ± 2.00
Change at Week 2 (n=44,46,46,48,45,43,44)0.03 ± 1.401.04 ± 4.490.24 ± 3.08-0.44 ± 3.80-0.18 ± 1.010.04 ± 2.590.36 ± 2.96
Change at Week 4 (n=44,43,45,48,44,39,43)0.48 ± 2.140.61 ± 2.95-0.11 ± 2.31-0.30 ± 4.210.10 ± 1.50-0.08 ± 2.370.52 ± 2.43
Change at Week 6 (n=43,44,43,48,42,41,43)1.03 ± 4.650.36 ± 2.77-0.01 ± 2.46-0.71 ± 4.850.13 ± 1.45-0.21 ± 2.510.59 ± 3.32
Change at Week 8 (n=45,46,47,48,47,43,45)0.55 ± 2.190.51 ± 2.93-0.18 ± 2.30-0.04 ± 5.010.08 ± 1.500.31 ± 3.540.52 ± 3.07
SecondaryChange From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8

OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort. Negative change from baseline indicated improvement.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · units on a scale
Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8
units on a scalePlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,44,47)45.0 ± 7.6643.9 ± 8.0944.8 ± 7.6946.0 ± 11.2245.4 ± 8.4142.3 ± 7.0147.4 ± 12.51
Change at Week 1 (n=45,45,47,47,44,41,43)-3.7 ± 7.28-5.9 ± 6.44-4.2 ± 6.49-3.9 ± 7.68-7.7 ± 9.99-4.3 ± 7.70-3.8 ± 7.79
Change at Week 2 (n=44,46,46,48,45,43,44)-6.3 ± 7.89-6.0 ± 5.92-6.2 ± 9.00-5.9 ± 7.30-7.6 ± 9.89-4.4 ± 9.13-6.8 ± 10.59
Change at Week 4 (n=44,43,45,48,44,41,43)-8.9 ± 8.44-7.6 ± 9.73-6.8 ± 8.58-5.7 ± 11.33-8.5 ± 10.88-6.1 ± 8.33-5.2 ± 8.23
Change at Week 6 (n=43,44,43,48,42,41,43)-10.1 ± 9.75-9.1 ± 9.35-8.8 ± 7.46-7.5 ± 10.31-8.0 ± 9.72-7.3 ± 10.88-7.2 ± 9.36
Change at Week 8 (n=45,46,47,48,47,44,44)-9.6 ± 8.98-9.9 ± 9.47-8.0 ± 8.81-7.4 ± 11.34-8.4 ± 9.42-8.8 ± 9.51-7.1 ± 10.16
SecondaryPercentage of Participants With >= 5 Units Decrease in Total OCI Score

OCI: validated questionnaire 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 Likert scale ranging from 0 (never) to 6 (always/severe). Total score was transformed to range of 0 to 100, higher score indicated more ocular discomfort.

Time frame:
Week 1, 2, 4, 6, 8
Reported as:
Number · percentage of participants
Percentage of Participants With >= 5 Units Decrease in Total OCI Score
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Week 144.453.338.353.256.843.939.5
Week 256.852.245.762.557.848.852.3
Week 468.260.555.658.365.951.246.5
Week 672.168.272.162.561.951.251.2
Week 864.471.759.660.457.459.152.3
SecondaryChange From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8

Daily artificial tear use was assessed by collecting data on daily number of drops of artificial tear instilled in the eye using a participant diary. Decrease in daily artificial tear use indicated improvement.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · drops/day
Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8
drops/dayPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline (n=47,46,47,48,48,43,47)3.4 ± 1.583.0 ± 1.633.0 ± 1.162.5 ± 1.653.0 ± 1.652.8 ± 1.202.9 ± 1.60
Change at Week 1 (n=45,46,47,48,47,43,45)-0.7 ± 1.27-1.1 ± 0.99-0.8 ± 1.01-0.8 ± 1.01-0.9 ± 1.33-1.1 ± 1.01-0.6 ± 1.17
Change at Week 2 (n=44,46,45,48,47,42,44)-0.9 ± 1.31-1.2 ± 1.09-0.8 ± 1.20-0.9 ± 0.99-0.9 ± 1.28-1.0 ± 1.03-0.6 ± 1.21
Change at Week 4 (n=44,44,45,48,45,41,44)-1.1 ± 1.60-1.5 ± 1.22-0.9 ± 1.08-1.0 ± 0.95-0.9 ± 1.29-1.2 ± 1.27-0.8 ± 1.42
Change at Week 6 (n=44,44,46,48,43,40,43)-1.5 ± 1.51-1.5 ± 1.08-0.9 ± 1.15-1.1 ± 1.07-1.0 ± 1.60-1.3 ± 1.10-0.7 ± 1.33
Change at Week 8 (n=46,46,47,48,47,43,46)-1.2 ± 1.36-1.6 ± 1.20-1.0 ± 1.19-1.2 ± 1.04-1.1 ± 1.52-1.5 ± 1.27-0.9 ± 1.34
SecondaryChange From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8

OSDI is a validated instrument for ocular surface disease. It has 12 items, each measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score (question 1 \[Q1\]-Q12) and three subscale scores can be derived: Ocular Symptom (Q1-Q3), Vision-related function (Q4-Q9), and Environmental trigger (Q10-Q12). Each derived score ranges from 0 to 100, with a higher score indicates worse condition.

Time frame:
Baseline, Week 1, 2, 4, 6, 8
Reported as:
Mean · units on a scale
Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8
units on a scalePlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline:total (n=47,46,46,48,48,43,47)37.6 ± 21.4635.6 ± 19.7131.5 ± 17.9541.8 ± 22.0437.8 ± 18.7635.6 ± 22.4541.8 ± 22.93
Baseline:symptoms (n=47,46,46,48,48,43,47)39.7 ± 22.8738.8 ± 21.6038.6 ± 20.6645.7 ± 24.3741.7 ± 22.8735.9 ± 20.8647.3 ± 24.64
Baseline:function (n=46,46,45,48,47,43,44)31.8 ± 21.0528.8 ± 20.3023.5 ± 19.5538.3 ± 26.6631.8 ± 20.7431.3 ± 27.0736.1 ± 26.02
Baseline:triggers (n=46,41,42,45,42,41,43)46.7 ± 30.8149.8 ± 29.6442.0 ± 31.6346.1 ± 29.6445.6 ± 29.5244.8 ± 26.9250.3 ± 30.12
Change at Week 1:total (n=45,45,46,47,44,40,43)-6.8 ± 14.39-5.1 ± 13.61-6.3 ± 13.79-8.9 ± 11.43-6.5 ± 17.18-9.2 ± 17.13-4.7 ± 12.46
Change at Week 1:symptoms (n=45,45,46,47,44,40,43)-5.9 ± 16.73-4.1 ± 15.85-8.5 ± 17.52-8.2 ± 17.59-6.3 ± 20.26-6.9 ± 17.99-4.5 ± 13.03
Change at Week 1:function (n=43,45,44,47,43,39,39)-6.1 ± 15.49-3.7 ± 16.32-4.4 ± 13.48-9.1 ± 14.77-4.4 ± 19.94-9.1 ± 17.81-7.3 ± 16.84
Change at Week 1:triggers (n=43,39,39,43,38,35,39)-7.9 ± 23.64-12.0 ± 24.05-6.6 ± 24.74-10.2 ± 18.88-14.7 ± 23.12-15.0 ± 28.19-2.4 ± 18.97
Change at Week 2:total (n=44,46,45,48,45,43,44)-8.7 ± 12.60-6.2 ± 12.09-8.6 ± 13.66-8.9 ± 13.08-4.7 ± 19.01-10.3 ± 20.16-7.3 ± 16.51
Change at Week 2:symptoms (n=44,46,45,48,45,43,44)-9.1 ± 18.49-6.2 ± 13.99-11.5 ± 17.79-11.5 ± 18.12-6.9 ± 19.41-9.7 ± 21.74-7.6 ± 17.77
Change at Week 2:function (n=42,46,42,48,43,43,41)-8.6 ± 14.26-5.8 ± 13.67-5.5 ± 12.92-7.6 ± 16.52-3.5 ± 23.92-7.0 ± 19.10-8.6 ± 19.44
Change at Week 2:triggers (n=42,40,40,38,35,39,40)-9.9 ± 18.38-7.9 ± 24.98-8.8 ± 24.76-9.4 ± 16.60-10.1 ± 29.00-19.2 ± 29.05-5.5 ± 21.42
Change at Week 4:total (n=44,43,44,48,44,41,43)-11.5 ± 15.88-7.2 ± 12.98-8.1 ± 15.53-9.7 ± 14.12-10.0 ± 20.92-11.3 ± 17.12-7.0 ± 13.95
Change at Week 4:symptoms (n=44,43,44,48,44,41,43)-12.1 ± 18.19-8.5 ± 12.79-13.4 ± 20.27-10.9 ± 18.37-10.8 ± 23.47-10.4 ± 18.61-6.6 ± 15.06
Change at Week 4:function (n=43,42,42,47,41,41,40)-10.2 ± 16.42-4.7 ± 15.98-6.3 ± 16.97-8.5 ± 16.77-5.1 ± 20.37-7.3 ± 18.75-8.7 ± 17.83
Change at Week 4:triggers (n=43,36,39,43,36,37,39)-13.5 ± 26.02-10.4 ± 21.90-5.8 ± 30.16-9.8 ± 23.23-16.3 ± 29.55-21.5 ± 25.07-4.7 ± 20.90
Change at Week 6:total (n=43,44,42,48,42,41,43)-10.5 ± 14.26-9.1 ± 14.19-7.9 ± 13.89-10.9 ± 14.33-8.1 ± 20.48-14.0 ± 19.43-7.7 ± 14.00
Change at Week 6:symptoms (n=43,44,42,48,42,41,43)-11.2 ± 18.36-10.0 ± 13.76-12.3 ± 17.96-11.4 ± 19.52-7.1 ± 21.03-13.4 ± 21.80-9.1 ± 15.52
Change at Week 6:function (n=42,44,38,46,40,41,40)-9.1 ± 18.88-7.0 ± 15.30-5.1 ± 14.46-9.6 ± 14.74-3.7 ± 20.10-9.3 ± 19.34-8.3 ± 17.09
Change at Week 6:triggers (n=40,38,37,41,34,38,39)-13.2 ± 21.62-13.0 ± 24.80-9.7 ± 23.61-9.2 ± 24.85-12.4 ± 32.88-24.5 ± 28.3-5.9 ± 22.65
Change at Week 8:total (n=45,46,46,48,32,35,39)-11.0 ± 18.55-8.5 ± 15.34-7.6 ± 15.22-8.8 ± 16.56-9.5 ± 20.92-12.7 ± 18.21-6.6 ± 16.11
Change at Week 8:symptoms (n=45,46,46,48,47,43,44)-13.1 ± 20.37-8.9 ± 16.14-11.6 ± 20.52-11.6 ± 20.68-10.5 ± 23.98-14.3 ± 21.54-7.4 ± 17.72
Change at Week 8:function (n=44,46,45,48,46,43,41)-9.1 ± 21.31-6.4 ± 16.54-4.5 ± 14.82-9.2 ± 18.33-6.2 ± 23.86-9.2 ± 18.31-6.8 ± 19.72
Change at Week 8:triggers(n=44,41,42,45,,41,41,41)-12.2 ± 24.86-14.2 ± 24.46-8.4 ± 23.62-6.4 ± 29.08-13.5 ± 29.07-19.6 ± 26.06-4.8 ± 23.62
SecondaryPercentage of Participants With >= 10 Units Decrease in Total OSDI Score

OSDI is a validated instrument for ocular surface disease. It has 12 items, each has a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time). Based on these item scores, a total OSDI score can be derived which ranges from 0 to 100; a higher score indicates worse ocular disease.

Time frame:
Week 1, 2, 4, 6, 8
Reported as:
Number · percentage of participants
Percentage of Participants With >= 10 Units Decrease in Total OSDI Score
percentage of participantsPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Week 137.837.834.846.845.540.037.2
Week 250.045.740.043.833.339.543.2
Week 447.744.238.650.045.541.544.2
Week 646.552.335.752.140.551.239.5
Week 840.050.041.347.944.746.538.6
SecondaryChange From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8

OSDI is a validated instrument for ocular surface disease. It has 12 items, each with a raw score measured on 5-point Likert scale (0=none of the time, 4=all the time).

Time frame:
Baseline, Week 1, 2, 4, 6, 8

No measurements were reported for this outcome.

SecondaryChange From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8

mOCI consisted of the original 12-item OCI plus additional questions on other dry eye symptoms and their impact to participant's life. Each item was measured on a 7-point Likert scale ranging from 0 (never) to 6 (always/severe). Negative change from baseline indicated improvement.

Time frame:
Baseline, Week 1, 2, 4, 6, 8

No measurements were reported for this outcome.

SecondaryChange From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8

NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: general health (GH), general vision (GV), ocular pain (OP), near activities (NAct), distance activities (DA), social functioning (SF), mental health (MH), role difficulties (RD), dependency, driving, color vision (CV) and peripheral vision (PV). Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, higher score=less symptoms/better visual functioning.

Time frame:
Baseline, Week 8
Reported as:
Mean · Units on a scale
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8
Units on a scalePlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Baseline: GH (n=46,46,47,48,48,43,47)65.22 ± 20.7466.85 ± 21.1262.77 ± 20.1066.15 ± 24.9959.90 ± 23.4966.86 ± 25.4357.98 ± 20.92
Baseline: GV (n=47,46,47,48,48,43,47)72.77 ± 16.3875.65 ± 12.5973.62 ± 14.5172.50 ± 20.0572.08 ± 13.5270.70 ± 17.1073.19 ± 13.37
Baseline: OP (n=47,46,47,48,48,43,47)59.31 ± 18.7059.51 ± 18.8561.17 ± 20.8953.65 ± 23.0655.47 ± 19.2856.40 ± 17.7650.27 ± 24.76
Baseline: NAct (n=47,46,47,48,48,43,47)68.62 ± 18.4970.92 ± 17.5376.60 ± 18.6064.41 ± 23.3666.06 ± 20.0172.00 ± 21.5364.36 ± 23.36
Baseline: DA (n=47,46,47,48,48,43,47)73.76 ± 17.6377.36 ± 17.7181.38 ± 16.3272.05 ± 25.1273.00 ± 17.1371.90 ± 20.6669.33 ± 21.92
Baseline: SF (n=47,46,47,48,48,43,47)89.10 ± 14.8993.21 ± 10.7793.88 ± 11.6286.46 ± 21.3989.84 ± 14.5187.79 ± 18.9985.64 ± 20.52
Baseline: MH (n=47,46,47,48,48,43,47)72.34 ± 24.5573.23 ± 19.8877.53 ± 19.7164.84 ± 26.1367.97 ± 22.9472.67 ± 22.2470.35 ± 23.73
Baseline: RD (n=47,46,47,48,48,43,47)68.09 ± 23.2872.83 ± 20.1276.33 ± 25.9661.98 ± 29.7367.71 ± 26.0268.02 ± 26.9168.09 ± 27.81
Baseline:dependency (n=47,45,47,47,48,43,47)88.48 ± 21.4693.89 ± 10.4294.33 ± 11.5481.91 ± 25.7988.02 ± 23.3487.79 ± 22.1589.72 ± 19.90
Baseline:driving (n=46,44,45,46,41,41,44)73.64 ± 17.1576.89 ± 15.6577.22 ± 19.0978.44 ± 20.3871.54 ± 22.2871.65 ± 21.2371.12 ± 19.80
Baseline: CV (n=46,46,47,48,48,43,47)89.67 ± 21.4696.20 ± 9.0893.62 ± 13.2690.10 ± 18.4193.75 ± 14.1291.28 ± 17.1590.43 ± 17.72
Baseline: PV (n=47,46,46,48,46,43,47)77.13 ± 23.2182.61 ± 20.3285.87 ± 21.5180.21 ± 25.2479.89 ± 21.4979.65 ± 26.3180.32 ± 22.68
Baseline: Overall (n=47,46,47,48,48,43,47)75.62 ± 14.4379.30 ± 10.9581.08 ± 12.9973.19 ± 19.3175.06 ± 13.9675.40 ± 15.5873.97 ± 16.76
Change at Week 8: GH (n=42,43,44,48,41,40,41)0.00 ± 13.53-2.91 ± 14.650.00 ± 15.252.08 ± 19.181.22 ± 18.50-0.63 ± 14.421.83 ± 10.29
Change at Week 8: GV (n=43,43,44,48,41,40,41)1.86 ± 16.221.86 ± 12.201.36 ± 7.953.75 ± 12.821.46 ± 18.115.00 ± 15.53-0.49 ± 10.48
Change at Week 8: OP (n=43,43,44,48,41,40,41)15.12 ± 19.5911.63 ± 21.8913.35 ± 20.959.38 ± 15.7911.59 ± 19.2416.56 ± 20.889.45 ± 19.72
Change at Week 8: NAct (n=43,43,44,48,41,40,41)7.17 ± 17.218.62 ± 15.334.17 ± 12.647.12 ± 16.4910.87 ± 19.077.40 ± 15.499.96 ± 19.65
Change at Week 8: DA (n=43,43,44,48,41,40,41)6.78 ± 12.505.43 ± 13.223.03 ± 13.464.43 ± 11.328.84 ± 17.888.85 ± 17.665.89 ± 14.67
Change at Week 8: SF (n=43,43,44,48,41,40,41)3.20 ± 12.822.62 ± 11.752.27 ± 10.543.39 ± 13.585.79 ± 13.436.88 ± 18.558.23 ± 12.06
Change at Week 8: MH (n=43,43,44,48,41,40,41)10.61 ± 19.279.59 ± 17.274.55 ± 13.575.34 ± 15.9511.28 ± 18.9210.63 ± 22.305.95 ± 16.41
Change at Week 8: RD (n=43,43,44,48,41,40,41)6.98 ± 15.745.52 ± 27.594.55 ± 20.375.47 ± 18.938.23 ± 24.9412.50 ± 25.940.00 ± 29.05
Change Week 8:dependency(n=43,42,44,47,41,40,41)7.56 ± 21.321.19 ± 15.791.89 ± 8.964.61 ± 14.835.39 ± 19.597.08 ± 17.452.24 ± 11.94
Change at Week 8:driving (n=42,41,42,46,33,38,39)6.15 ± 14.473.46 ± 16.243.27 ± 13.640.36 ± 12.293.91 ± 14.438.22 ± 13.653.95 ± 13.07
Change at Week 8: CV (n=42,43,44,48,41,40,41)4.76 ± 13.792.33 ± 9.153.98 ± 10.712.08 ± 16.972.44 ± 13.475.63 ± 19.194.88 ± 16.03
Change at Week 8: PV (n=43,43,44,48,39,40,41)11.05 ± 22.034.07 ± 15.361.70 ± 15.623.65 ± 18.596.41 ± 21.246.88 ± 20.406.71 ± 20.17
Change at Week 8: Overall (n=43,43,44,48,41,40,41)7.44 ± 9.555.13 ± 9.203.98 ± 7.444.50 ± 8.197.15 ± 11.608.67 ± 11.505.15 ± 10.42

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Twice Daily—0/47 (0%)23/47 (48.9%)
CP-690,550, 0.0003% Twice Daily—1/46 (2.2%)11/46 (23.9%)
CP-690,550, 0.001% Twice Daily—0/47 (0%)22/47 (46.8%)
CP-690,550, 0.003% Twice Daily—1/48 (2.1%)21/48 (43.8%)
CP-690,550, 0.005% Twice Daily—1/48 (2.1%)15/48 (31.3%)
CP-690,550, 0.005% Once Daily—1/44 (2.3%)15/44 (34.1%)
Restasis Twice Daily—1/47 (2.1%)26/47 (55.3%)
Most frequent serious events
Most frequent serious events
EventPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Hip fractureInjury, poisoning and procedural complications0/470/460/470/480/481/440/47
PneumoniaInfections and infestations0/471/460/470/480/480/440/47
ThrombosisVascular disorders0/471/460/470/480/480/440/47
Drug exposure during pregnancyInjury, poisoning and procedural complications0/470/460/470/480/480/441/47
DiverticulitisInfections and infestations0/470/460/471/480/480/440/47
FallInjury, poisoning and procedural complications0/470/460/470/481/480/440/47
Lower limb fractureInjury, poisoning and procedural complications0/470/460/470/481/480/440/47
SyncopeNervous system disorders0/470/460/470/481/480/440/47
Most frequent other events
Showing 10 of 130
Most frequent other events
EventPlacebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice Daily
Visual acuity reduced, STUDY EYE ONLYEye disorders1/470/463/470/480/480/440/47
Instillation site pain, BOTH EYESGeneral disorders0/470/461/471/481/482/443/47
Upper respiratory tract infectionInfections and infestations0/470/463/470/480/482/441/47
Eye pain, BOTH EYESEye disorders1/470/460/471/481/482/441/47
Eye pruritus, BOTH EYESEye disorders0/470/461/470/480/482/440/47
Meibomian gland dysfunction, BOTH EYESEye disorders0/470/461/470/480/482/440/47
Urinary tract infectionInfections and infestations0/470/461/471/480/482/441/47
Corneal erosion, BOTH EYESEye disorders0/472/461/470/480/480/440/47
Ocular hyperaemia, BOTH EYESEye disorders0/472/461/471/481/480/441/47
HeadacheNervous system disorders0/472/460/470/481/480/440/47

Baseline characteristics

Age Continuous
Age Continuous(years)Placebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice DailyTotal
Mean62.3 ± 12.5459.5 ± 11.5760.7 ± 11.7358.7 ± 14.5759.9 ± 11.6959.8 ± 14.8358.9 ± 14.2560.0 ± 13.02
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Twice DailyCP-690,550, 0.0003% Twice DailyCP-690,550, 0.001% Twice DailyCP-690,550, 0.003% Twice DailyCP-690,550, 0.005% Twice DailyCP-690,550, 0.005% Once DailyRestasis Twice DailyTotal
Female32354034393738255
Male151171497972
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Study locations

27 sites
  • Pfizer Investigational Site
    Chandler, Arizona 85286, United States
  • Pfizer Investigational Site
    Peoria, Arizona 85381, United States
  • Pfizer Investigational Site
    Phoenix, Arizona 85032, United States
  • Pfizer Investigational Site
    Artesia, California 90701, United States
  • Pfizer Investigational Site
    Centennial, Colorado 80112, United States
  • Pfizer Investigational Site
    Ormond Beach, Florida 32174, United States
  • Pfizer Investigational Site
    Stuart, Florida 34994, United States
  • Pfizer Investigational Site
    Tamarac, Florida 33321, United States
  • Pfizer Investigational Site
    Tampa, Florida 33603, United States
  • Pfizer Investigational Site
    Atlanta, Georgia 30342, United States
  • Pfizer Investigational Site
    Morrow, Georgia 30260, United States
  • Pfizer Investigational Site
    Roswell, Georgia 30076, United States
  • Pfizer Investigational Site
    Louisville, Kentucky 40217, United States
  • Pfizer Investigational Site
    Baltimore, Maryland 21287, United States
  • Pfizer Investigational Site
    Boston, Massachusetts 02114, United States
  • Pfizer Investigational Site
    Kansas City, Missouri 64111, United States
  • Pfizer Investigational Site
    Lynbrook, New York 11563, United States
  • Pfizer Investigational Site
    Rochester, New York 14618, United States
  • Pfizer Investigational Site
    Charlotte, North Carolina 28210, United States
  • Pfizer Investigational Site
    High Point, North Carolina 27262, United States
  • Pfizer Investigational Site
    Cleveland, Ohio 44115, United States
  • Pfizer Investigational Site
    Columbus, Ohio 43210, United States
  • Pfizer Investigational Site
    Memphis, Tennessee 38119, United States
  • Pfizer Investigational Site
    Austin, Texas 78705, United States
  • Pfizer Investigational Site
    Austin, Texas 78731, United States
  • Pfizer Investigational Site
    Austin, Texas 78746, United States
  • Pfizer Investigational Site
    San Antonio, Texas 78240, United States
09

References and documents

Publications

  • Liew MS, Zhang M, Kim E, Akpek EK. Prevalence and predictors of Sjogren's syndrome in a prospective cohort of patients with aqueous-deficient dry eye. Br J Ophthalmol. 2012 Dec;96(12):1498-503. doi: 10.1136/bjophthalmol-2012-301767. Epub 2012 Sep 21. PubMed 23001257 ↗
  • Huang JF, Yafawi R, Zhang M, McDowell M, Rittenhouse KD, Sace F, Liew SH, Cooper SR, Pickering EH. Immunomodulatory effect of the topical ophthalmic Janus kinase inhibitor tofacitinib (CP-690,550) in patients with dry eye disease. Ophthalmology. 2012 Jul;119(7):e43-50. doi: 10.1016/j.ophtha.2012.03.017. Epub 2012 May 18. PubMed 22607938 ↗
  • Liew SH, Nichols KK, Klamerus KJ, Li JZ, Zhang M, Foulks GN. Tofacitinib (CP-690,550), a Janus kinase inhibitor for dry eye disease: results from a phase 1/2 trial. Ophthalmology. 2012 Jul;119(7):1328-35. doi: 10.1016/j.ophtha.2012.01.028. Epub 2012 Apr 22. PubMed 22525048 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00784719
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 4, 2008
Start date
Nov 2008
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Apr 9, 2013
Last update
Apr 9, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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