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

Glaucoma is the world's the second leading cause of irreversible blindness. The World Health Organization (WHO) estimated the incidence of blindness due to glaucoma to be 4.4 million people worldwide in 2002. Intraocular pressure (IOP) is the sole proven modifiable risk factor for the development and progression of glaucomatous optic neuropathy. Medical therapy is aimed at lowering IOP in order to prevent or slow progression.

Exfoliation syndrome (XFS) is the most common identifiable cause of open-angle glaucoma, affecting an estimated 60 to 70 million people worldwide. Approximately two-thirds of patients have disease in only one eye on clinical examination; however, XFS is detectable in the other eye with conjunctival biopsy. XFS is also a systemic disease, with effects on the cardiovascular and cerebrovascular systems.

Patients with XFS are twice as likely to convert from ocular hypertension to glaucoma. Glaucoma in XFS is more severe than primary open angle glaucoma. There is greater diurnal IOP fluctuation, greater visual field loss and optic nerve head damage at the time of diagnosis, poorer response to medications, more rapid visual field progression and more frequent need for surgery.

Because you meet eligibility criteria for our study, we ask for your consent to participate in the study described below. In brief, you will be taking an investigational drug (AR-12286, rho-kinase Inhibitor) at either 0.5% or 0.7% once a day for 6 months. This drug is currently being tested in patients with primary open-angle glaucoma, but not yet in glaucoma in exfoliation syndrome. Because of the mechanism of glaucoma in XFS and the mechanism of action of rho-kinase inhibitors, there is reason to think it would be more effective in eyes with XFS and glaucoma than in primary open-angle glaucoma (ordinary glaucoma). There will be a baseline and study day 1 visit, week 1 visit, month 1 and 3 visit, week 13 visit, month 6 visit and a week 25 visit; for a total of 7 office visits.

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Key information

Conditions

Exfoliation Syndrome Eye Diseases Glaucoma Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Open Angle Glaucoma Uveal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glaucoma Associates of New York

New York, 10003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

AR-12286

Drug

Other names: Rho-Kinase Inhibitor

Primary outcomes

Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)

Time frame: 6 months

Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.

Sponsors and collaborators

Lead sponsor

Robert Ritch, MD, LLC.

Other

Registry information

Acronym: ROCK

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Sep 6, 2013
Registry last updated: Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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