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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

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.

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1 - AMA0076 Dose A (or vehicle)

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).

Group Type EXPERIMENTAL

AMA0076

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 2: AMA0076 Dose B (or vehicle)

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).

Group Type EXPERIMENTAL

AMA0076

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 3: AMA0076 Dose C (or vehicle)

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).

Group Type EXPERIMENTAL

AMA0076

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 4: AMA0076 Dose D (or vehicle)

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).

Group Type EXPERIMENTAL

AMA0076

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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AMA0076

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No