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A Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention | Clinical Trials | Clareo Health

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A Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

NCT02174991•New York Glaucoma Research Institute

View on ClinicalTrials.gov

Summary

A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are facing surgical intervention. Patients will be treated for 6 months in this initial trial. B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of surgical intervention.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with open-angle glaucoma.
•2. IOP above the target range or visual field progression with use of maximum standard drug therapy.
•3. Have given written informed consent, prior to any investigational procedures.
•4. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria

•1. Angle-closure glaucoma
•2. Eyes having had previous incisional glaucoma surgery
•3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
•4. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study).
•5. Any abnormality preventing reliable applanation tonometry of the treated eye.
•6. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
•7. Participation in any investigational study within the past 30 days.
•8. Inability to perform reliable visual field testing.
•9. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
•10. Self-reported poor compliance to treatment.
+2 more criteria

Locations (1)

Glaucoma Associates of New York

New York, New York, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

February 1, 2015

Last Updated

April 24, 2015

Enrollment

ESTIMATED participants

Conditions

Glaucoma

Interventions

Rho-Kinase Inhibitor (AR-12286)

DRUG

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT04354545

GlaucomaOcular Surface Disease

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RECRUITINGNA

Automated Applanation Tonometry - Updated

NCT07298356

GlaucomaGlaucoma, Suspect

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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 24, 2015Data 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 Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

Inclusion Criteria

Exclusion Criteria

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