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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Soilsh Practice
    • Petaluma, California, United States, 94954
      • Bacharach practice
  • Florida
    • Brooksville, Florida, United States, 34613
      • Hernando Eye Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mundorf Practice
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.	One week

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Thomas Van Haarlem, MD, Aerie Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: August 30, 2007
• First Submitted That Met QC Criteria: August 30, 2007
• First Posted (Estimate): August 31, 2007

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: AR102-CS201