Ocular Hypotensive Efficacy of AR-102

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523250
• Other study ID #: AR102-CS201
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2007
• Last updated: April 18, 2014
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2014
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• AR-102 0.003% Ophthalmic Solution

• AR-102 0.005% Ophthalmic Solution

• AR-102 0.01% Ophthalmic Solution

• AR-102 0.03% Ophthalmic Solution

• AR-102 Vehicle Ophthalmic Solution

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas
United States	Hernando Eye Institute	Brooksville	Florida
United States	Mundorf Practice	Charlotte	North Carolina
United States	Taustine Eye Center	Louisville	Kentucky
United States	Soilsh Practice	Pasadena	California
United States	Bacharach practice	Petaluma	California
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.		One week	No
Secondary	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	No