Overview

This trial is active, not recruiting.

Conditions glaucoma, ocular hypertension, eye disease
Treatments ama0076, placebo
Phase phase 2
Sponsor Amakem, NV
Start date April 2014
End date September 2014
Trial size 80 participants
Trial identifier NCT02136940, AMA0076-S-202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
ama0076
(Experimental)
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
ama0076
(Experimental)
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
ama0076
(Placebo Comparator)
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
placebo

Primary Outcomes

Measure
Mean change from baseline in mean diurnal intraocular pressure
time frame: 4 weeks

Secondary Outcomes

Measure
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.
time frame: 4 weeks
Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 30 years up to 85 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Amakem, NV.