Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

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

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

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: Adults 30-85 years of age. Diagnosis of either POAG or OHT 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 ≤ 33 mm Hg at 8 AM and ≥ 21 and ≤ 33 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment [after a washout phase in those subjects who were receiving ocular hypotensive therapy]). Exclusion Criteria: Ophthalmic exclusion criteria: Uncontrolled intraocular hypertension defined as > 33 mm Hg in either eye 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 in either eye at time of screening. Abnormal central corneal thickness. BCVA worse than 20/200 (logMAR 1.0) in either eye Significant visual field loss. 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: AMA0076 0.1%<br>Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. | Drug: AMA0076<br> <br> |
| Experimental: AMA0076 0.25%<br>Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. | Drug: AMA0076<br> <br> |
| Experimental: AMA0076 0.50%<br>Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. | Drug: AMA0076<br> <br> |
| Placebo Comparator: Placebo<br>Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in mean diurnal intraocular pressure |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean, mean change and percent change from baseline in intraocular pressure in both mean diurnal intraocular pressure and intraocular pressure at equivalent diurnal time points. |  | 4 weeks | 
| Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables | Evaluation of safety variables including eye exam findings (best corrected visual acuity, biomicroscopy [including grading of conjunctival hyperemia], dilated fundus examination) adverse events, discontinuations due to adverse events, serious adverse events, and vital signs. | 4 weeks |