Ocular Hypotensive Efficacy of AR-102 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Glaucoma	Drug: AR-102 Drug: Vehicle	Phase II

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official 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

Further study details as provided by Aerie Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point. [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AR-102: Experimental AR-102	Drug: AR-102 AR-102 Ophthalmic Solution
Vehicle: Placebo Comparator AR-102 Vehicle	Drug: Vehicle AR-102 Vehicle

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523250

Locations


United States, California
	Soilsh Practice
	Pasadena, California, United States, 91105
	Bacharach practice
	Petaluma, California, United States, 94954

United States, Florida
	Hernando Eye Institute
	Brooksville, Florida, United States, 34613

United States, Kentucky
	Taustine Eye Center
	Louisville, Kentucky, United States, 40217

United States, North Carolina
	Mundorf Practice
	Charlotte, North Carolina, United States, 28204

United States, South Dakota
	Black Hills Regional Eye Institute
	Rapid City, South Dakota, United States, 57701

United States, Texas
	Medical Center Ophthalmology Associates
	San Antonio, Texas, United States, 78240
	Texan Eye Care
	Austin, Texas, United States, 78746

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators


Study Director:	Thomas Van Haarlem, MD	Aerie Pharmaceuticals, Inc.

More Information

Responsible Party:	Aerie Pharmaceuticals, Inc. ( Thomas van Haarlem, M.D. )
Study ID Numbers:	AR102-CS201
First Received:	August 30, 2007
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00523250
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:

Glaucoma

Study placed in the following topic categories:

Glaucoma

Eye Diseases

Hypertension

Ocular Hypertension

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Aerie Pharmaceuticals
Information provided by:	Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00523250