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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)

Primary Purpose

Exfoliation Syndrome, Ocular Hypertension, Open Angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AR-12286
Sponsored by
Robert Ritch, MD, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exfoliation Syndrome

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glaucoma Associates of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

0.5%

0.7%

Arm Description

0.5% Rho-Kinase Inhibitor

0.7% Rho-Kinase Inhibitor

Outcomes

Primary Outcome Measures

Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)
Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.

Secondary Outcome Measures

Full Information

First Posted
August 28, 2013
Last Updated
October 17, 2018
Sponsor
Robert Ritch, MD, LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT01936389
Brief 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
Acronym
ROCK
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Robert Ritch, MD, LLC.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exfoliation Syndrome, Ocular Hypertension, Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.5%
Arm Type
Experimental
Arm Description
0.5% Rho-Kinase Inhibitor
Arm Title
0.7%
Arm Type
Experimental
Arm Description
0.7% Rho-Kinase Inhibitor
Intervention Type
Drug
Intervention Name(s)
AR-12286
Other Intervention Name(s)
Rho-Kinase Inhibitor
Primary Outcome Measure Information:
Title
Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)
Description
Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Glaucoma Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

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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

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