Ocular Hypotensive Efficacy of AR-102

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.

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

Details

• Lead Sponsor: Aerie Pharmaceuticals
• Treatments: Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 18 years of age or greater (male, or female not of childbearing potential).

• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).

• Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better

Exclusion Criteria:

• Known hypersensitivity to any component of the formulation or to topical anesthetics

• Previous glaucoma intraocular surgery or laser procedures in study eye(s)

• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.

• Participation in any study involving an investigational drug within the past 30 days.