Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).

Conditions
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Pterygium

Intervention / Treatment
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* Drug: cyclosporine ophthalmic emulsion 0.05%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a pterygium in at least one eye that has not been previously removed with surgery Exclusion Criteria: Uncontrolled systemic disease Active eye disease Current or anticipated use of topical eye medications other than artificial tears. Anticipated wearing of contact lenses

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cyclosporine ophthalmic emulsion 0.05%<br>One drop in the study eye (or eyes) administered four times daily (QID) | Drug: cyclosporine ophthalmic emulsion 0.05%<br>* One drop in the study eye (or eyes) administered four times daily (QID)<br>* Other names: RESTASIS®;|
| Placebo Comparator: Vehicle<br>One drop in the study eye (or eyes) administered four times daily (QID) | Drug: Vehicle<br>* One drop in the study eye (or eyes) administered four times daily (QID)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pterygium Hyperemia Responders at Week 16 | Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia. | Week 16 | 
| Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16 | Change from Baseline in Severity Grade of Pterygium Hyperemia at Week 16. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A negative number change from baseline is an improvement and a positive number change from baseline is a worsening. | Baseline, Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16 | Change from baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire score at Week 16. The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement. | Baseline, Week 16 |