Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
Overview
- Phase
- Phase 2
- Intervention
- cyclosporine ophthalmic emulsion 0.05%
- Conditions
- Pterygium
- Sponsor
- Allergan
- Enrollment
- 115
- Primary Endpoint
- Number of Pterygium Hyperemia Responders at Week 16
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
cyclosporine ophthalmic emulsion 0.05%
One drop in the study eye (or eyes) administered four times daily (QID)
Intervention: cyclosporine ophthalmic emulsion 0.05%
Vehicle
One drop in the study eye (or eyes) administered four times daily (QID)
Intervention: Vehicle
Outcomes
Primary Outcomes
Number of Pterygium Hyperemia Responders at Week 16
Time Frame: 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.
Change From Baseline in Severity Grade of Pterygium Hyperemia at Week 16
Time Frame: Baseline, 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.
Secondary Outcomes
- Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16(Baseline, Week 16)