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

Sponsor

Amakem, NV (Industry)

Overall Status

Completed

CT.gov ID

NCT01693315

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

13.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension Eye Disease	Drug: AMA0076 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: AMA0076 Drug: Placebo
Experimental: 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).	Drug: AMA0076 Drug: Placebo
Experimental: 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).	Drug: AMA0076 Drug: Placebo
Experimental: 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).	Drug: AMA0076 Drug: Placebo

Outcome Measures

Primary Outcome Measures

intraocular pressure change from baseline. [4 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria include:

Adults 30-85 years of age
Diagnosis of either ocular hypertension or primary open-angle glaucoma 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 ≤ 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:

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).
Receiving more than one medication for IOP at time of screening.
Central corneal thickness of less than 500 µm or greater than 620 µm.
BCVA worse than 20/200 in either eye
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.
Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.

Contacts and Locations

Locations

	Site	City	State	Country
1	Artesia Clinical Site - Site 02	Artesia	California	United States
2	Inglewood Clinical Site - Site 03	Inglewood	California	United States
3	Petaluma Clinical Site - Site 05	Petaluma	California	United States
4	New Haven Clinical Site - Site 01	New Haven	Connecticut	United States
5	Atlanta Clinical Site - Site 04	Atlanta	Georgia	United States
6	High Point Clinical Site - Site 06	High Point	North Carolina	United States