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Ocular Hypotensive Efficacy of AR-102

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523250
First Posted: August 31, 2007
Last Update Posted: May 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aerie Pharmaceuticals
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Texan Eye
Austin, Texas, United States, 78731
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
Study Director: Thomas Van Haarlem, MD Aerie Pharmaceuticals, Inc.
  More Information

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00523250     History of Changes
Other Study ID Numbers: AR102-CS201
First Submitted: August 30, 2007
First Posted: August 31, 2007
Last Update Posted: May 8, 2014
Last Verified: April 2014

Keywords provided by Aerie Pharmaceuticals:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents