Advanced Glaucoma
Conditions
Brief summary
A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled IOP who are facing further surgical intervention. Patients will be treated for 6 months in this initial trial. B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of further surgical intervention.
Interventions
Sponsors
New York Glaucoma Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients older than 18 years of either sex. 2. Patients with open-angle glaucoma with prior glaucoma filtering surgery. 3. IOP above the target range or visual field progression. 4. Have given written informed consent, prior to any investigational procedures. 5. Ability to attend for the 6-month duration of treatment.
Exclusion criteria
1. Closed angle glaucoma (primary or secondary). 2. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics. 3. 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). 4. Any abnormality preventing reliable applanation tonometry of the treated eye. 5. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 6. Participation in any investigational study within the past 30 days. 7. Inability to perform reliable visual field testing. 8. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary. 9. Self-reported poor compliance to treatment. 10. Reluctance to return for scheduled follow-up visits. 11. Patients not able to understand the nature of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of study drug to reduce IOP | 6 Months | To evaluate the ocular hypotensive efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients with uncontrolled Advanced Glaucoma with Prior Failed Trabeculectomy or Tube Shunt. The long lasting effect of the AR-12286 drug is hoped to increase aqueous outflow and clear the trabecular meshwork of material and reduce IOP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP Reduction | 6 Months | To determine if AR-12286 can be used as directed therapy for Advanced Glaucoma with Prior Failed Trabeculectomy or Tube Shunt to avoid additional surgical intervention. |
Countries
United States
Outcome results
None listed