Title
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
Phase
Phase 2Lead Sponsor
Aerie PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
GlaucomaIntervention/Treatment
quinine ...Study Participants
82A 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.
