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Completed

NCT Number: NCT00523250

Ocular Hypotensive Efficacy of AR-102

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soilsh Practice, Pasadena, California, United States

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About this study

A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or greater (male, or female not of childbearing potential).
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).
  • Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better

Exclusion criteria

  • Known hypersensitivity to any component of the formulation or to topical anesthetics
  • Previous glaucoma intraocular surgery or laser procedures in study eye(s)
  • Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
  • Participation in any study involving an investigational drug within the past 30 days.

Treatment and study plan

AR-102 0.003% Ophthalmic Solution

Drug

AR-102 0.005% Ophthalmic Solution

Drug

AR-102 0.01% Ophthalmic Solution

Drug

AR-102 0.03% Ophthalmic Solution

Drug

AR-102 Vehicle Ophthalmic Solution

Drug

Primary outcomes

  1. The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.

    Time frame: One week

Secondary outcomes

  1. The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires

    Time frame: One week

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 31, 2007
Registry last updated
May 8, 2014

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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