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OpenTrials
Completed

NCT Number: NCT01693315

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

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.

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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 - Site 02, 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

include:

  • Adults 30-85 years of age
  • Diagnosis of either ocular hypertension or primary open-angle glaucoma 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 ≤ 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:

  • 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).
  • Receiving more than one medication for IOP at time of screening.
  • Central corneal thickness of less than 500 µm or greater than 620 µm.
  • BCVA worse than 20/200 in either eye
  • 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.
  • 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. intraocular pressure change from baseline.

    Time frame: 4 weeks

Secondary outcomes

  1. Adverse events as a measure of safety/tolerability

    Time frame: 4 weeks

  2. IOP assessments at weekly visits

    Time frame: Weeks 1, 2, 3, 4

Sponsors and collaborators

Lead sponsor

Amakem, NV

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Jul 17, 2013

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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