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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 (ROCK - CACG)

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ClinicalTrials.gov Identifier: NCT02152774
Recruitment Status : Unknown
Verified April 2015 by Jessica Jasien, New York Glaucoma Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jessica Jasien, New York Glaucoma Research Institute

Tracking Information
First Submitted Date  ICMJE May 23, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date April 24, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Long Lasting effect of study drug to reduce IOP [ Time Frame: 6 Months ]
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with CACG treated for 6 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Secondary Outcome [ Time Frame: 6 Months ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Angle-closure Glaucoma
Intervention  ICMJE Drug: Rho-Kinase Inhibitor
Study Arms  ICMJE
  • Experimental: 0.5% Rho-Kinase Inhibitor
    AR-12286 is a novel, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork Rho-kinase AR-12286 is well tolerated and produces clinically and statistically significant ocular hypotensive efficacy in patients with ocular hypertension and glaucoma. It is well tolerated by most patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing.
    Intervention: Drug: Rho-Kinase Inhibitor
  • Experimental: 0.7% Rho-Kinase Inhibitor
    AR-12286 is a novel, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork Rho-kinase AR-12286 is well tolerated and produces clinically and statistically significant ocular hypotensive efficacy in patients with ocular hypertension and glaucoma. It is well tolerated by most patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing.
    Intervention: Drug: Rho-Kinase Inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients between 50 and 85 years old; of either sex.
  2. Patients with CACG with ≥180⁰ PAS
  3. IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
  4. No previous intraocular surgery except clear cornea phacoemulsification.
  5. Corrected visual acuity in both eyes ≥20/50 in the eligible eye
  6. Not more than 6 diopters spherical equivalent on the study eye
  7. Not more than 3 diopters cylinder equivalent on the study eye
  8. Have given written informed consent, prior to any investigational procedures.
  9. Ability to attend for the 6-month duration of the study

Exclusion Criteria:

  1. Open angle glaucoma
  2. Closed angle glaucoma with <180⁰ PAS
  3. Intraocular pressure >35 mmHg
  4. Severe glaucomatous damage
  5. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
  6. Previous intraocular surgery except clear cornea phacoemulsification.
  7. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study.
  8. 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).
  9. Any abnormality preventing reliable applanation tonometry of either eye.
  10. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  11. Changes of systemic medication that could have a substantial effect on IOP anticipated during the study.
  12. Participation in any investigational study within the past 30 days.
  13. Inability to perform reliable VF testing.
  14. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
  15. Self-reported poor compliance to treatment.
  16. Reluctance to return for scheduled follow-up visits.
  17. Patients not able to understand the nature of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152774
Other Study ID Numbers  ICMJE 14.12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jessica Jasien, New York Glaucoma Research Institute
Study Sponsor  ICMJE New York Glaucoma Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account New York Glaucoma Research Institute
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP