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

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension; Eye Disease
• Interventions: Drug: AMA0076; Drug: Placebo

• Registration Number: NCT01693315
• Lead Sponsor: Amakem, NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-26
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-16
• Last Update Posted: 2013-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 - AMA0076 Dose A (or vehicle)	AMA0076	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).
Cohort 1 - AMA0076 Dose A (or vehicle)	Placebo	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).
Cohort 2: AMA0076 Dose B (or vehicle)	Placebo	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).
Cohort 3: AMA0076 Dose C (or vehicle)	Placebo	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).
Cohort 4: AMA0076 Dose D (or vehicle)	Placebo	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).
Cohort 2: AMA0076 Dose B (or vehicle)	AMA0076	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).
Cohort 3: AMA0076 Dose C (or vehicle)	AMA0076	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).
Cohort 4: AMA0076 Dose D (or vehicle)	AMA0076	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).

Primary Outcome Measures

Name	Time	Method
intraocular pressure change from baseline.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events as a measure of safety/tolerability	4 weeks
IOP assessments at weekly visits	Weeks 1, 2, 3, 4

Trial Locations

Locations (6)

Petaluma Clinical Site - Site 05; 🇺🇸 Petaluma, California, United States

Artesia Clinical Site - Site 02; 🇺🇸 Artesia, California, United States

Inglewood Clinical Site - Site 03; 🇺🇸 Inglewood, California, United States

Atlanta Clinical Site - Site 04; 🇺🇸 Atlanta, Georgia, United States

New Haven Clinical Site - Site 01; 🇺🇸 New Haven, Connecticut, United States

High Point Clinical Site - Site 06; 🇺🇸 High Point, North Carolina, United States