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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

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.

Condition or disease Intervention/treatment Phase
Chronic Angle-closure Glaucoma Drug: Rho-Kinase Inhibitor Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Chronic Angle-closure Glaucoma
Study Start Date : May 2014
Actual Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Drug: Rho-Kinase Inhibitor



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT02152774


Locations
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
Sponsors and Collaborators
New York Glaucoma Research Institute

Responsible Party: Jessica Jasien, Co-Investigator, New York Glaucoma Research Institute
ClinicalTrials.gov Identifier: NCT02152774     History of Changes
Other Study ID Numbers: 14.12
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Antihypertensive Agents
Pharmaceutical Solutions