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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:30 - 85
Updated:5/27/2013
Start Date:September 2012
End Date:August 2013
Contact:John P. Hall
Phone:732-556-6055

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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


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.


Inclusion Criteria include:

1. Adults 30-85 years of age

2. Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes

3. 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

4. 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:

1. 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).

2. Receiving more than one medication for IOP at time of screening.

3. Central corneal thickness of less than 500 µm or greater than 620 µm.

4. BCVA worse than 20/200 in either eye

5. 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.

6. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in
either eye.
We found this trial at
6
sites
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Atlanta, GA
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Artesia, California
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Artesia, CA
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High Point, North Carolina
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High Point, NC
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Inglewood, California
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Inglewood, CA
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New Haven, Connecticut
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New Haven, CT
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Petaluma, California
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Petaluma, CA
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