Ocular Hypotensive Efficacy of AR-102

Completed · Phase 2

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT00523250

Run by

Aerie Pharmaceuticals

People needed

82

Starts

2007-09-01

Expected to finish

2008-03-01

Last updated by the study team

2014-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Mundorf Practice — Charlotte, North Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Texan Eye — Austin, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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