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
Overview
- Phase
- Phase 2
- Intervention
- AR-102 0.003% Ophthalmic Solution
- Conditions
- Glaucoma
- Sponsor
- Aerie Pharmaceuticals
- Enrollment
- 82
- Locations
- 8
- Primary Endpoint
- The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility 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.
Arms & Interventions
AR-102 0.003% Ophthalmic Solution
q.d. ocular
Intervention: AR-102 0.003% Ophthalmic Solution
AR-102 0.005% Ophthalmic Solution
q.d. ocular
Intervention: AR-102 0.005% Ophthalmic Solution
AR-102 0.01% Ophthalmic Solution
q.d. ocular
Intervention: AR-102 0.01% Ophthalmic Solution
AR-102 0.03% Ophthalmic Solution
q.d. ocular
Intervention: AR-102 0.03% Ophthalmic Solution
AR-102 Vehicle Ophthalmic Solution
q.d. ocular
Intervention: AR-102 Vehicle Ophthalmic Solution
Outcomes
Primary Outcomes
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
Time Frame: One week
Secondary Outcomes
- The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires(One week)