Ocular Hypotensive Efficacy of AR-102

Phase 2

Completed

• Conditions: Glaucoma
• Interventions: Drug: AR-102 0.003% Ophthalmic Solution; Drug: AR-102 0.005% Ophthalmic Solution; Drug: AR-102 0.01% Ophthalmic Solution; Drug: AR-102 0.03% Ophthalmic Solution; Drug: AR-102 Vehicle Ophthalmic Solution

• Registration Number: NCT00523250
• Lead Sponsor: Aerie Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Study Start: 2007-09
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Disposition First Submitted: 2014-02-17
• Disposition First Submitted QC: 2014-03-25
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-18
• Disposition First Posted: 2014-04-21
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR-102 0.003% Ophthalmic Solution	AR-102 0.003% Ophthalmic Solution	q.d. ocular
AR-102 0.005% Ophthalmic Solution	AR-102 0.005% Ophthalmic Solution	q.d. ocular
AR-102 0.01% Ophthalmic Solution	AR-102 0.01% Ophthalmic Solution	q.d. ocular
AR-102 0.03% Ophthalmic Solution	AR-102 0.03% Ophthalmic Solution	q.d. ocular
AR-102 Vehicle Ophthalmic Solution	AR-102 Vehicle Ophthalmic Solution	q.d. ocular

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.	One week

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Soilsh Practice; 🇺🇸 Pasadena, California, United States

Bacharach practice; 🇺🇸 Petaluma, California, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Texan Eye; 🇺🇸 Austin, Texas, United States

Mundorf Practice; 🇺🇸 Charlotte, North Carolina, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States

Hernando Eye Institute; 🇺🇸 Brooksville, Florida, United States

Taustine Eye Center; 🇺🇸 Louisville, Kentucky, United States