A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% iā¦ (NCT02152774) | Clinical Trial Compass
UnknownPhase 2
A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma
United States10 participantsStarted 2014-05
Plain-language summary
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6 months.
Secondary Outcome
Secondary objectives are:
1. To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular pressure (IOP).
2. To evaluate the long term effect of the drug on IOP.
3. To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.
Who can participate
Age range50 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Patients between 50 and 85 years old; of either sex.
ā. Patients with CACG with ā„180ā° PAS
ā. IOP ā„22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
ā. No previous intraocular surgery except clear cornea phacoemulsification.
ā. Corrected visual acuity in both eyes ā„20/50 in the eligible eye
ā. Not more than 6 diopters spherical equivalent on the study eye
ā. Not more than 3 diopters cylinder equivalent on the study eye
ā. Have given written informed consent, prior to any investigational procedures.
ā. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
ā. Previous intraocular surgery except clear cornea phacoemulsification.
ā. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study.
ā. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or drops for treatment of dry eye syndrome (which may be used throughout the study).