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A Study of AR-12286 in Patient With Elevated Intraocular Pressure (IOP) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of AR-12286 in Patient With Elevated Intraocular Pressure (IOP)

A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 Ophthalmic Solution 0.05%, 0.1% and 0.25% in Patients With Elevated Intraocular Pressure

NCT00902200•Aerie Pharmaceuticals

View on ClinicalTrials.gov

Summary

Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.

Detailed Description

Subjects will be randomized to receive AR-12286 Ophthalmic Solution 0.05%, 0.1%, and 0.25% or its vehicle (one eye), q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. The first dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout this period.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age or greater.
•2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). Unmedicated (post-washout, if required) IOP \>= 24 mm Hg in one or both eyes at 08:00 hours, \>= 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
•3. Corrected visual acuity in each eye +1.0 logMAR (logarithm mininum angle of resolution) or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
•4. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria

•Either eye
•1. Intraocular pressure \> 36 mm Hg
•2. Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
•3. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
•4. History or evidence of ocular infection inflammation, or of herpes simplex keratitis, or clinically significant blepharitis or conjunctivitis at baseline (Visit 1)..
•5. Contact lens wear within 30 minutes of instillation of study medication.
•6. Ocular medication of any kind within 30 days of Visit 2, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 2) or c) lubricating drops for dry eye (which may be used throughout the study),
•7. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (i.e., cup-disc ratio \> 0.8).
•8. Central corneal thickness greater than 600 microns.
•9. Any abnormality preventing reliable applanation tonometry.
+11 more criteria

Locations (8)

Soilsh Practice

Pasadena, California, United States

Bacharach practice

Petaluma, California, United States

Hernando Eye Institute

Brooksville, Florida, United States

Taustine Eye Center

Louisville, Kentucky, United States

Mundorf Practice

Charlotte, North Carolina, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Texan Eye

Austin, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

April 21, 2014

Enrollment

ACTUAL participants

Conditions

Elevated Intraocular Pressure

Interventions

AR-12286

DRUG

AR-12286 vehicle

DRUG

Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure

NCT04962009

Elevated Intraocular Pressure (IOP)

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COMPLETEDPHASE2

Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

NCT01896180

Primary Open Angle GlaucomaOcular Hypertension+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AR-12286 in Patient With Elevated Intraocular Pressure (IOP)

Inclusion Criteria

Exclusion Criteria

Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure

Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

Intraocular Pressure Accuracy and Variability of the Barraquer Tonometer