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

Allergan

Status and phase: Completed; Phase 2

Conditions: Pterygium

Treatments: Drug: Vehicle; Drug: cyclosporine ophthalmic emulsion 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01109056

192371-019

Details and patient eligibility

About

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).

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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115 participants in 2 patient groups, including a placebo group

cyclosporine ophthalmic emulsion 0.05%

Experimental group

Description:

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

Treatment:

Drug: cyclosporine ophthalmic emulsion 0.05%

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle