A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt

Advanced Glaucoma Clinical Trial

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 Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02173223
• Other study ID #: 14.14
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 17, 2014
• Last updated: April 23, 2015
• Start date: June 2014

Study information

• Verified date: April 2015
• Source: New York Glaucoma Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Glaucoma
• Glaucoma

Intervention

Drug:
• Rho-Kinase Inhibitor

Locations

Country	Name	City	State
United States	Glaucoma Associates of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Glaucoma Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	6 Months	Yes
Secondary	IOP Reduction	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.	6 Months	Yes