Ocular Hypotensive Efficacy of AR-102

A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure

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.

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.

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.