Chronic Angle-closure Glaucoma Clinical Trial
— ROCK - CACGOfficial 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
| NCT number | NCT02152774 |
| Other study ID # | 14.12 |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | Phase 2 |
| First received | May 23, 2014 |
| Last updated | April 23, 2015 |
| Start date | May 2014 |
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.
| Status | Active, not recruiting |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 85 Years |
| Eligibility |
Inclusion Criteria: 1. Patients between 50 and 85 years old; of either sex. 2. Patients with CACG with =180° 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 <180° 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Glaucoma Associates of New York | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| New York Glaucoma Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Long Lasting effect of study drug to reduce IOP | 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. | 6 Months | Yes |
| Secondary | Secondary Outcome | 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. | 6 Months | Yes |