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OpenTrials
Completed

NCT Number: NCT02136940

Multiple Dose-parallel-group Study of AMA0076 in Patients 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.

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Key information

Conditions

Glaucoma Eye Disease Eye Diseases Ocular Hypertension

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Artesia Clinical - Site 11, Artesia, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMA0076

Drug

Placebo

Drug

Primary outcomes

  1. Mean change from baseline in mean diurnal intraocular pressure

    Time frame: 4 weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amakem, NV

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 13, 2014
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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