We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01693315
First Posted: September 26, 2012
Last Update Posted: July 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amakem, NV
  Purpose
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 Intervention Phase
Glaucoma Ocular Hypertension Eye Disease Drug: AMA0076 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amakem, NV:

Primary Outcome Measures:
  • intraocular pressure change from baseline. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Adverse events as a measure of safety/tolerability [ Time Frame: 4 weeks ]
  • IOP assessments at weekly visits [ Time Frame: Weeks 1, 2, 3, 4 ]

Enrollment: 82
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  1. Adults 30-85 years of age
  2. Diagnosis of either ocular hypertension or primary open-angle glaucoma in both eyes
  3. 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
  4. 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:

  1. 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).
  2. Receiving more than one medication for IOP at time of screening.
  3. Central corneal thickness of less than 500 µm or greater than 620 µm.
  4. BCVA worse than 20/200 in either eye
  5. 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.
  6. Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693315


Locations
United States, California
Artesia Clinical Site - Site 02
Artesia, California, United States
Inglewood Clinical Site - Site 03
Inglewood, California, United States
Petaluma Clinical Site - Site 05
Petaluma, California, United States
United States, Connecticut
New Haven Clinical Site - Site 01
New Haven, Connecticut, United States
United States, Georgia
Atlanta Clinical Site - Site 04
Atlanta, Georgia, United States
United States, North Carolina
High Point Clinical Site - Site 06
High Point, North Carolina, United States
Sponsors and Collaborators
Amakem, NV
  More Information

Responsible Party: Amakem, NV
ClinicalTrials.gov Identifier: NCT01693315     History of Changes
Other Study ID Numbers: AMA0076-201
First Submitted: September 21, 2012
First Posted: September 26, 2012
Last Update Posted: July 17, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases