Clinical trial NCT02152774: 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: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Angle-closure Glaucoma
Lead sponsor: New York Glaucoma Research Institute
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Long Lasting effect of study drug to reduce IOP
timeFrame: 6 Months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
Study officials:
References: