A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Robert Ritch, MD, LLC.
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
50-85 y.o.
Male and Female
Exfoliation Syndrome and ocular hypertension or mild or moderate exfoliative glaucoma
IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
No previous intraocular surgery except clear cornea phacoemulsification
Corrected visual acuity in both eyes ≥20/50 in the eligible eye
Not more than 6 diopters spherical equivalent on the study eye
Not more than 3 diopters cylinder equivalent on the study eye
Have given written informed consent, prior to any investigational procedures
Ability to attend for the 6-month duration of the study
You may not be if
Open angle glaucoma other than exfoliative glaucoma
Closed angle glaucoma (primary or secondary)
Intraocular pressure \>30 mm Hg
Severe exfoliation glaucoma
Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics
Previous intraocular surgery except clear cornea phacoemulsification
Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study
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 either eye
Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study
Changes of systemic medication that could have a substantial effect on IOP anticipated during the study
Participation in any investigational study within the past 30 days
Inability to perform reliable VF 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
Clareo Health | A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
