Ocular Hypotensive Efficacy of AR-102 - Full Text View

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

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 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	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Blood Pressure Medicines 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 ]

Enrollment:	82
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
Pharmaceutical: Experimental AR-102	Drug: AR-102 0.003% Ophthalmic Solution q.d. ocular Drug: AR-102 0.005% Ophthalmic Solution q.d. ocular Drug: AR-102 0.01% Ophthalmic Solution q.d. ocular Drug: AR-102 0.03% Ophthalmic Solution q.d. ocular Drug: AR-102 Vehicle Ophthalmic Solution q.d. ocular

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
Austin, Texas, United States, 78731

Sponsors and Collaborators

Aerie Pharmaceuticals

Investigators

Study Director:

Thomas Van Haarlem, MD

Aerie Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Aerie Pharmaceuticals, Inc. ( Thomas van Haarlem, M.D. )
Study ID Numbers:	AR102-CS201
Study First Received:	August 30, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00523250 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:

Glaucoma

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cardiovascular Agents

Antihypertensive Agents
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Therapeutic Uses
Eye Diseases
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009