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

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ClinicalTrials.gov Identifier: NCT02136940
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Amakem, NV

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mean change from baseline in mean diurnal intraocular pressure [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 4 weeks ]
  2. Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables [ Time Frame: 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
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT02136940


Locations
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United States, California
Artesia Clinical - Site 11
Artesia, California, United States
Inglewood Clinical Site - Site 15
Inglewood, California, United States
Petaluma Clinical Site - Site 17
Petaluma, California, United States
United States, Georgia
Morrow Clinical Site - Site13
Morrow, Georgia, United States
Roswell Clinical Site - Site 18
Roswell, Georgia, United States
United States, New York
Rochester Clinical Site - Site 12
Rochester, New York, United States
Slingerlands Clinical Site - Site 19
Slingerlands, New York, United States
United States, North Carolina
Charlotte Clinical Site - Site 14
Charlotte, North Carolina, United States
High Point Clinical Site - Site 16
High Point, North Carolina, United States
Sponsors and Collaborators
Amakem, NV
More Information
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Responsible Party: Amakem, NV
ClinicalTrials.gov Identifier: NCT02136940    
Other Study ID Numbers: AMA0076-S-202
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
 Hypertension
Vascular Diseases
Cardiovascular Diseases