Ocular Hypotensive Efficacy of AR-102

Study Overview
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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.

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.

Official Title
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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

Conditions
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Glaucoma

Intervention / Treatment
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* 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


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AR-102 0.003% Ophthalmic Solution<br>q.d. ocular | Drug: AR-102 0.003% Ophthalmic Solution<br> <br> |
| Experimental: AR-102 0.005% Ophthalmic Solution<br>q.d. ocular | Drug: AR-102 0.005% Ophthalmic Solution<br> <br> |
| Experimental: AR-102 0.01% Ophthalmic Solution<br>q.d. ocular | Drug: AR-102 0.01% Ophthalmic Solution<br> <br> |
| Experimental: AR-102 0.03% Ophthalmic Solution<br>q.d. ocular | Drug: AR-102 0.03% Ophthalmic Solution<br> <br> |
| Experimental: AR-102 Vehicle Ophthalmic Solution<br>q.d. ocular | Drug: AR-102 Vehicle Ophthalmic Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point. |  | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma