Ocular Hypotensive Efficacy of AR-102

NCT00523250 | Completed Phase 2

• 1 other identifier: AR102-CS201
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 8

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.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.

  One week

Secondary Outcomes (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

Study Arms (5)

AR-102 0.003% Ophthalmic Solution

EXPERIMENTAL

q.d. ocular

Drug: AR-102 0.003% Ophthalmic Solution

AR-102 0.005% Ophthalmic Solution

EXPERIMENTAL

q.d. ocular

Drug: AR-102 0.005% Ophthalmic Solution

AR-102 0.01% Ophthalmic Solution

EXPERIMENTAL

q.d. ocular

Drug: AR-102 0.01% Ophthalmic Solution

AR-102 0.03% Ophthalmic Solution

EXPERIMENTAL

q.d. ocular

Drug: AR-102 0.03% Ophthalmic Solution

AR-102 Vehicle Ophthalmic Solution

EXPERIMENTAL

q.d. ocular

Drug: AR-102 Vehicle Ophthalmic Solution

Interventions

AR-102 0.003% Ophthalmic Solution DRUG

AR-102 0.003% Ophthalmic Solution

AR-102 0.005% Ophthalmic Solution DRUG

AR-102 0.005% Ophthalmic Solution

AR-102 0.01% Ophthalmic Solution DRUG

AR-102 0.01% Ophthalmic Solution

AR-102 0.03% Ophthalmic Solution DRUG

AR-102 0.03% Ophthalmic Solution

AR-102 Vehicle Ophthalmic Solution DRUG

AR-102 Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (8)

Soilsh Practice

Pasadena, California, 91105, United States

Location

Bacharach practice

Petaluma, California, 94954, United States

Location

Hernando Eye Institute

Brooksville, Florida, 34613, United States

Location

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Mundorf Practice

Charlotte, North Carolina, 28204, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Thomas Van Haarlem, MD

  Aerie Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: August 31, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 8, 2014

Record last verified: 2014-04

Locations

US (8)