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
This trial is active, not recruiting.
|Treatment||rho-kinase inhibitor (ar-12286)|
|Sponsor||New York Glaucoma Research Institute|
|Start date||June 2014|
|End date||February 2015|
|Trial size||10 participants|
|Trial identifier||NCT02174991, 14.15|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
time frame: 6 Months
Tolerance and Lasting IOP Effect
time frame: 6 Months
Male or female participants of any age.
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.
|Official title||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|
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