Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Signs and symptoms of dry eye disease

• Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.

Exclusion Criteria:

• History of glaucoma, or ocular hypertension

• Diagnosis of ocular infection

• Use of contact lenses in the past 14 days or expected use during the study

• Use of any topical ophthalmic medications in the past 30 days

• Use of corticosteroids in the past 30 days.