Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma

Study Overview
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Brief Summary
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The objective of this dose-escalation study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension or primary open-angle glaucoma.

Official Title
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A Phase 2a, Randomized, Double-masked, Placebo-controlled, Dose-escalation Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma

Conditions
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Glaucoma, Ocular Hypertension, Eye Disease

Intervention / Treatment
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* Drug: AMA0076
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: Adults 30-85 years of age Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease Elevated IOP (≥ 24 and ≤ 34 mm Hg at 8 AM and ≥ 21 and ≤ 34 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment Exclusion Criteria include: Uncontrolled intraocular hypertension defined as >34 mm Hg at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy). Receiving more than one medication for IOP at time of screening. Central corneal thickness of less than 500 µm or greater than 620 µm. BCVA worse than 20/200 in either eye Significant visual field loss (ie, mean deviation > 10 db or field loss within 10 degrees of fixation), a new field defect, or progression of an existing field defect in either eye during the year preceding the study. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - AMA0076 Dose A (or vehicle)<br>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo). | Drug: AMA0076<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 2: AMA0076 Dose B (or vehicle)<br>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo). | Drug: AMA0076<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 3: AMA0076 Dose C (or vehicle)<br>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo). | Drug: AMA0076<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 4: AMA0076 Dose D (or vehicle)<br>Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo). | Drug: AMA0076<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure change from baseline. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events as a measure of safety/tolerability |  | 4 weeks | 
| IOP assessments at weekly visits |  | Weeks 1, 2, 3, 4 |