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

Phase 2

Completed

• Conditions: Pterygium
• Interventions: Drug: cyclosporine ophthalmic emulsion 0.05%; Drug: Vehicle

• Registration Number: NCT01109056
• Lead Sponsor: Allergan

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-06
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2012-05
• Results First Submitted: 2012-05-22
• Results First Submitted QC: 2012-05-22
• Last Update Submitted: 2012-05-22
• Results First Posted: 2012-06-25
• Last Update Posted: 2012-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cyclosporine ophthalmic emulsion 0.05%	cyclosporine ophthalmic emulsion 0.05%	One drop in the study eye (or eyes) administered four times daily (QID)
Vehicle	Vehicle	One drop in the study eye (or eyes) administered four times daily (QID)

Primary Outcome Measures

Name	Time	Method
Number of Pterygium Hyperemia Responders at Week 16	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Surface Disease Index© (OSDI©) Questionnaire Score at Week 16	Baseline, 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.