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Ocular Hypotensive Efficacy of AR-102

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00523250
First received: August 30, 2007
Last updated: April 18, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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
Experimental: AR-102 0.003% Ophthalmic Solution
q.d. ocular
Drug: AR-102 0.003% Ophthalmic Solution
None
Experimental: AR-102 0.005% Ophthalmic Solution
q.d. ocular
Drug: AR-102 0.005% Ophthalmic Solution
None
Experimental: AR-102 0.01% Ophthalmic Solution
q.d. ocular
Drug: AR-102 0.01% Ophthalmic Solution
None
Experimental: AR-102 0.03% Ophthalmic Solution
q.d. ocular
Drug: AR-102 0.03% Ophthalmic Solution
None
Experimental: AR-102 Vehicle Ophthalmic Solution
q.d. ocular
Drug: AR-102 Vehicle Ophthalmic Solution
None

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided

Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00523250     History of Changes
Other Study ID Numbers: AR102-CS201
Study First Received: August 30, 2007
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Aerie Pharmaceuticals:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014