Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Official Title
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Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: AL-12182 0.003% Ophthalmic Solution
* Other: AL-12182 Ophthalmic Solution Vehicle
* Drug: Latanoprost 0.005% Ophthalmic Solution
* Drug: AL-12182 0.01% Ophthalmic Solution
* Drug: AL-12182 0.03% Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Diagnosis of open-angle glaucoma or ocular hypertension. LogMAR visual acuity not worse than 0.6. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Clinically relevant ophthalmic or systemic conditions. Other protocol-defined exclusion criteria may apply.

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: AL-12182 0.003%<br>One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days | Drug: AL-12182 0.003% Ophthalmic Solution<br>* Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>|
| Placebo Comparator: AL-12182 Solution Vehicle<br>One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days | Other: AL-12182 Ophthalmic Solution Vehicle<br>* Placebo<br>|
| Active Comparator: Latanoprost<br>One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days | Drug: Latanoprost 0.005% Ophthalmic Solution<br>* Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>|
| Experimental: AL-12182 0.01%<br>One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days | Drug: AL-12182 0.01% Ophthalmic Solution<br>* Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>|
| Experimental: AL-12182 0.03%<br>One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days | Drug: AL-12182 0.03% Ophthalmic Solution<br>* Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open-angle, glaucoma, ocular, hypertension, POAG