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 (ROCK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01936389|
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : April 24, 2015
Last Update Posted : November 16, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Exfoliation Syndrome Ocular Hypertension Open Angle Glaucoma||Drug: AR-12286||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
0.5% Rho-Kinase Inhibitor
Other Name: Rho-Kinase Inhibitor
0.7% Rho-Kinase Inhibitor
Other Name: Rho-Kinase Inhibitor
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936389
|United States, New York|
|Glaucoma Associates of New York|
|New York, New York, United States, 10003|