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.
- Patients with open-angle glaucoma.
- IOP above the target range or visual field progression with use of maximum standard drug therapy.
- Have given written informed consent, prior to any investigational procedures.
- Ability to attend for the 6-month duration of treatment.
- Angle-closure glaucoma
- Eyes having had previous incisional glaucoma surgery
- 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 Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention|
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