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Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02136940•Amakem, NV

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - 85 years

Sex

ALL

Healthy Volunteers

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

•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.

Locations (9)

Artesia Clinical - Site 11

Artesia, California, United States

Inglewood Clinical Site - Site 15

Inglewood, California, United States

Petaluma Clinical Site - Site 17

Petaluma, California, United States

Morrow Clinical Site - Site13

Morrow, Georgia, United States

Roswell Clinical Site - Site 18

Roswell, Georgia, United States

Rochester Clinical Site - Site 12

Rochester, New York, United States

Slingerlands Clinical Site - Site 19

Slingerlands, New York, United States

Charlotte Clinical Site - Site 14

Charlotte, North Carolina, United States

High Point Clinical Site - Site 16

High Point, North Carolina, United States

Key Dates

Start Date

April 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

December 1, 2014

Last Updated

January 21, 2015

Enrollment

103

ACTUAL participants

Conditions

GlaucomaOcular HypertensionEye Disease

Interventions

AMA0076

DRUG

Placebo

DRUG

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT04354545

GlaucomaOcular Surface Disease

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RECRUITINGPHASE4

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

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