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

Sponsor

Amakem, NV (Industry)

Overall Status

Completed

CT.gov ID

NCT02136940

Collaborator

(none)

103

Enrollment

Locations

Arms

Duration (Months)

11.4

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMA0076 0.1% Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.	Drug: AMA0076
Experimental: AMA0076 0.25% Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.	Drug: AMA0076
Experimental: AMA0076 0.50% Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.	Drug: AMA0076
Placebo Comparator: Placebo Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Mean change from baseline in mean diurnal intraocular pressure [4 weeks]

Secondary Outcome Measures

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. [4 weeks]
Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables [4 weeks]
Evaluation of safety variables including eye exam findings (best corrected visual acuity, biomicroscopy [including grading of conjunctival hyperemia], dilated fundus examination) adverse events, discontinuations due to adverse events, serious adverse events, and vital signs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Artesia Clinical - Site 11	Artesia	California	United States
2	Inglewood Clinical Site - Site 15	Inglewood	California	United States
3	Petaluma Clinical Site - Site 17	Petaluma	California	United States
4	Morrow Clinical Site - Site13	Morrow	Georgia	United States
5	Roswell Clinical Site - Site 18	Roswell	Georgia	United States
6	Rochester Clinical Site - Site 12	Rochester	New York	United States
7	Slingerlands Clinical Site - Site 19	Slingerlands	New York	United States
8	Charlotte Clinical Site - Site 14	Charlotte	North Carolina	United States
9	High Point Clinical Site - Site 16	High Point	North Carolina	United States