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.
- Patients older than 18 years of either sex.
- Patients with open-angle glaucoma with prior glaucoma filtering surgery.
- IOP above the target range or visual field progression.
- Have given written informed consent, prior to any investigational procedures.
- Ability to attend for the 6-month duration of treatment.
- Closed angle glaucoma (primary or secondary).
- Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
- 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).
- Any abnormality preventing reliable applanation tonometry of the treated eye.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
- Participation in any investigational study within the past 30 days.
- Inability to perform reliable visual field testing.
- Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
- Self-reported poor compliance to treatment.
- Reluctance to return for scheduled follow-up visits.
- 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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