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

August 30, 2007
April 18, 2014
September 2007
March 2008   (final data collection date for primary outcome measure)
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 ]
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point. [ Time Frame: One week ]
Complete list of historical versions of study NCT00523250 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Ocular Hypotensive Efficacy of AR-102
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: AR-102 0.003% Ophthalmic Solution
    None
  • Drug: AR-102 0.005% Ophthalmic Solution
    None
  • Drug: AR-102 0.01% Ophthalmic Solution
    None
  • Drug: AR-102 0.03% Ophthalmic Solution
    None
  • Drug: AR-102 Vehicle Ophthalmic Solution
    None
  • Experimental: AR-102 0.003% Ophthalmic Solution
    q.d. ocular
    Intervention: Drug: AR-102 0.003% Ophthalmic Solution
  • Experimental: AR-102 0.005% Ophthalmic Solution
    q.d. ocular
    Intervention: Drug: AR-102 0.005% Ophthalmic Solution
  • Experimental: AR-102 0.01% Ophthalmic Solution
    q.d. ocular
    Intervention: Drug: AR-102 0.01% Ophthalmic Solution
  • Experimental: AR-102 0.03% Ophthalmic Solution
    q.d. ocular
    Intervention: Drug: AR-102 0.03% Ophthalmic Solution
  • Experimental: AR-102 Vehicle Ophthalmic Solution
    q.d. ocular
    Intervention: Drug: AR-102 Vehicle Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523250
AR102-CS201
No
Aerie Pharmaceuticals
Aerie Pharmaceuticals
Not Provided
Study Director: Thomas Van Haarlem, MD Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP