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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Eye Disease
• Intervention / Treatment: Drug: Placebo; Drug: AMA0076

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States
      • Artesia Clinical - Site 11
    • Inglewood, California, United States
      • Inglewood Clinical Site - Site 15
    • Petaluma, California, United States
      • Petaluma Clinical Site - Site 17
  • Georgia
    • Morrow, Georgia, United States
      • Morrow Clinical Site - Site13
    • Roswell, Georgia, United States
      • Roswell Clinical Site - Site 18
  • New York
    • Rochester, New York, United States
      • Rochester Clinical Site - Site 12
    • Slingerlands, New York, United States
      • Slingerlands Clinical Site - Site 19
  • North Carolina
    • Charlotte, North Carolina, United States
      • Charlotte Clinical Site - Site 14
    • High Point, North Carolina, United States
      • High Point Clinical Site - Site 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in mean diurnal intraocular pressure	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	4 weeks

Collaborators and Investigators

• Sponsor: Amakem, NV

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 9, 2014
• First Submitted That Met QC Criteria: May 9, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 16, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Eye Diseases
• Other Study ID Numbers: AMA0076-S-202