A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
This trial is active, not recruiting.
|Sponsor||New York Glaucoma Research Institute|
|Start date||June 2014|
|End date||February 2015|
|Trial size||10 participants|
|Trial identifier||NCT02173223, 14.14|
A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled IOP who are facing further 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 further surgical intervention.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Effect of study drug to reduce IOP
time frame: 6 Months
time frame: 6 Months
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Patients older than 18 years of either sex. 2. Patients with open-angle glaucoma with prior glaucoma filtering surgery. 3. IOP above the target range or visual field progression. 4. Have given written informed consent, prior to any investigational procedures. 5. Ability to attend for the 6-month duration of treatment. Exclusion Criteria: 1. Closed angle glaucoma (primary or secondary). 2. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics. 3. 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). 4. Any abnormality preventing reliable applanation tonometry of the treated eye. 5. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 6. Participation in any investigational study within the past 30 days. 7. Inability to perform reliable visual field testing. 8. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary. 9. Self-reported poor compliance to treatment. 10. Reluctance to return for scheduled follow-up visits. 11. Patients not able to understand the nature of the study.
|Official title||A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt|
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