A Phase 4 interventional study of Cyclosporine 0.05% Ophthalmic Emulsion in Dry Eye Syndromes, sponsored by Allergan. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
This study will evaluate the efficacy of Restasis® in participants with dry eye disease who engage in electronic visual tasking.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion:
1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Drug: Cyclosporine 0.05% Ophthalmic Emulsion
Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
Also known as: RESTASIS®
Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye
Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Month 6
Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye
Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Month 6
Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye
Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Month 6
Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye
Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Month 6
Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye
Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Month 6
Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye
Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
Time frame: Baseline, Month 6
Change From Baseline in Font Size
The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
Time frame: Baseline, Month 6
Change From Baseline in Words Read Incorrectly
The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.
Time frame: Baseline, Month 6
Change From Baseline in Time to Read Passage
The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).
Time frame: Baseline, Month 6
Change From Baseline in Reading Rate
Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).
Time frame: Baseline, Month 6
Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye
TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.
Time frame: Baseline, Month 6
Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye
A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.
Time frame: Baseline, Month 6
Change From Baseline in Interblink Interval (IBI) in the Worst Eye
A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.
Time frame: Baseline, Month 6
Change From Baseline in OSDI© Total Score
The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 6
Change From Baseline in Driving at Night on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
Time frame: Baseline, Month 6
Change From Baseline in Working With a Computer or Bank Machine on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
Time frame: Baseline, Month 6
Change From Baseline in Watching Television (TV) on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
Time frame: Baseline, Month 6
Change From Baseline in Blurred Vision on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
Time frame: Baseline, Month 6
Change From Baseline in Poor Vision on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
Time frame: Baseline, Month 6
Change From Baseline in Reading on the OSDI©
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
Time frame: Baseline, Month 6
Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye
Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement.
Time frame: Baseline, Month 6
| Milestone | RESTASIS® |
|---|---|
| Started | 51 |
| Completed | 46 |
| Not completed | 5 |
| Withdrew: Adverse event | 1 |
| Withdrew: Administrative reasons | 1 |
| Withdrew: Other miscellaneous reasons | 3 |
Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 7.05 ± 1.011 |
| Change from Baseline at Month 6 | -1.51 ± 1.466 |
Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 4.57 ± 1.237 |
| Change from Baseline at Month 6 | -0.61 ± 1.238 |
Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 2.29 ± 0.441 |
| Change from Baseline at Month 6 | -0.75 ± 0.656 |
Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 4.00 ± 1.378 |
| Change from Baseline at Month 6 | -0.34 ± 1.418 |
Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 3.99 ± 1.486 |
| Change from Baseline at Month 6 | -0.18 ± 1.235 |
Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 0.85 ± 0.822 |
| Change from Baseline at Month 6 | -0.24 ± 0.524 |
The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.
| points | RESTASIS® |
|---|---|
| Baseline | 9.0 ± 0.00 |
| Change from Baseline at Month 6 | 0.0 ± 0.21 |
The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.
| incorrect words | RESTASIS® |
|---|---|
| Baseline | 16.6 ± 22.00 |
| Change from Baseline at Month 6 | -4.1 ± 16.64 |
The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).
| seconds | RESTASIS® |
|---|---|
| Baseline | 126.0 ± 28.64 |
| Change from Baseline at Month 6 | -0.7 ± 24.48 |
Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).
| correct words/minute | RESTASIS® |
|---|---|
| Baseline | 146.6 ± 64.18 |
| Change from Baseline at Month 6 | -3.6 ± 69.80 |
TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.
| seconds | RESTASIS® |
|---|---|
| Baseline | 2.38 ± 1.073 |
| Change from Baseline at Month 6 | -0.31 ± 1.258 |
A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.
| percent of area | RESTASIS® |
|---|---|
| Baseline | 1.38 ± 2.064 |
| Change from Baseline at Month 6 | -0.87 ± 1.975 |
A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.
| seconds | RESTASIS® |
|---|---|
| Baseline | 5.27 ± 6.052 |
| Change from Baseline at Month 6 | -1.16 ± 6.399 |
The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 45.1 ± 17.76 |
| Change from Baseline at Month 6 | -14.9 ± 16.50 |
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 1.7 ± 1.30 |
| Change from Baseline at Month 6 | -0.5 ± 1.14 |
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 1.9 ± 1.03 |
| Change from Baseline at Month 6 | -0.8 ± 1.08 |
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 1.8 ± 1.11 |
| Change from Baseline at Month 6 | -0.9 ± 1.12 |
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 1.7 ± 1.18 |
| Change from Baseline at Month 6 | -0.6 ± 0.86 |
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 1.5 ± 1.23 |
| Change from Baseline at Month 6 | -0.5 ± 0.84 |
The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 1.5 ± 1.25 |
| Change from Baseline at Month 6 | -0.3 ± 1.15 |
Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement.
| score on a scale | RESTASIS® |
|---|---|
| Baseline | 3.08 ± 1.017 |
| Change from Baseline at Month 6 | -0.60 ± 1.232 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RESTASIS® | — | 3/50 (6%) | 6/50 (12%) |
| Event | RESTASIS® |
|---|---|
| Papillary thyroid carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/50 |
| Peripheral vascular diseaseVascular disorders | 1/50 |
| Carbon monoxide poisoningInjury, poisoning and procedural complications | 1/50 |
| Event | RESTASIS® |
|---|---|
| Visual acuity reducedEye disorders | 3/50 |
| NasopharyngitisInfections and infestations | 3/50 |
51 participants were initially enrolled in the study, 1 participant discontinued before dosing and is not included in the Intent-to-treat (ITT) population.
| Age, Continuous(years) | RESTASIS® |
|---|---|
| Mean | 46.3 ± 8.3 |
| Sex: Female, Male(Participants) | RESTASIS® |
|---|---|
| Female | 41 |
| Male | 9 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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