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Ocular Hypotensive Efficacy of AR-102

Sponsor
Aerie Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00523250
Collaborator
(none)
82
Enrollment
8
Locations
5
Arms
6
Duration (Months)
10.3
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
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
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  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 [One week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Soilsh Practice Pasadena California United States 91105
2 Bacharach practice Petaluma California United States 94954
3 Hernando Eye Institute Brooksville Florida United States 34613
4 Taustine Eye Center Louisville Kentucky United States 40217
5 Mundorf Practice Charlotte North Carolina United States 28204
6 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
7 Texan Eye Austin Texas United States 78731
8 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00523250
Other Study ID Numbers:
  • AR102-CS201
First Posted:
Aug 31, 2007
Last Update Posted:
May 8, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Aerie Pharmaceuticals
Glaucoma
Additional relevant MeSH terms:
Glaucoma
Pharmaceutical Solutions
Ophthalmic Solutions

Study Results

No Results Posted as of May 8, 2014