Ocular Hypotensive Efficacy of AR-102

Aerie Pharmaceuticals82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glaucoma

Interventions

AR-102 0.003% Ophthalmic SolutionDRUG

AR-102 0.005% Ophthalmic SolutionDRUG

AR-102 0.01% Ophthalmic SolutionDRUG

AR-102 0.03% Ophthalmic Solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Soilsh Practice

Pasadena, California, United States

Bacharach practice

Petaluma, California, United States

Hernando Eye Institute

Brooksville, Florida, United States

Taustine Eye Center

Louisville, Kentucky, United States

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

Time frame: One week

Data from ClinicalTrials.gov

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