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

Allergan115 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

115

Conditions

Pterygium

Interventions

cyclosporine ophthalmic emulsion 0.05%DRUG

One drop in the study eye (or eyes) administered four times daily (QID)

VehicleDRUG

One drop in the study eye (or eyes) administered four times daily (QID)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Glendale, California, United States

Unnamed facility

Randwick, New South Wales, Australia

Unnamed facility

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, Week 16

Secondary Outcomes

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.

Time frame: Baseline, Week 16

Data from ClinicalTrials.gov

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