Ocular Hypotensive Efficacy of AR-102

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AR-102 0.003% Ophthalmic Solution

q.d. ocular

Group Type EXPERIMENTAL

AR-102 0.003% Ophthalmic Solution

Intervention Type DRUG

AR-102 0.005% Ophthalmic Solution

q.d. ocular

Group Type EXPERIMENTAL

AR-102 0.005% Ophthalmic Solution

Intervention Type DRUG

AR-102 0.01% Ophthalmic Solution

q.d. ocular

Group Type EXPERIMENTAL

AR-102 0.01% Ophthalmic Solution

Intervention Type DRUG

AR-102 0.03% Ophthalmic Solution

q.d. ocular

Group Type EXPERIMENTAL

AR-102 0.03% Ophthalmic Solution

Intervention Type DRUG

AR-102 Vehicle Ophthalmic Solution

q.d. ocular

Group Type EXPERIMENTAL

AR-102 Vehicle Ophthalmic Solution

Intervention Type DRUG

Interventions

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AR-102 0.003% Ophthalmic Solution

Intervention Type DRUG

AR-102 0.005% Ophthalmic Solution

Intervention Type DRUG

AR-102 0.01% Ophthalmic Solution

Intervention Type DRUG

AR-102 0.03% Ophthalmic Solution

Intervention Type DRUG

AR-102 Vehicle Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No