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

New York Glaucoma Research Institute10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Glaucoma

Interventions

Rho-Kinase Inhibitor (AR-12286)DRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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. 11. Reluctance to return for scheduled follow-up visits. 12. Patients not able to understand the nature of the study.

Outcomes

Primary Outcomes

IOP Reduction

Avoid surgical intervention of glaucoma treatment with use of AR-12286; long lasting effect of study drug to reduce IOP by increase of aqueous outflow

Time frame: 6 Months

Secondary Outcomes

Tolerance and Lasting IOP Effect

To evaluate the ocular hypotensive safety (tolerance) of Rho-Kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solution in patients who are avoiding surgical intervention and the long last effect of IOP reduction.