A Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

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 Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02174991
• Other study ID #: 14.15
• 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 open-angle glaucoma patients with uncontrolled IOP who are facing 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 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: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with open-angle glaucoma.

2. IOP above the target range or visual field progression with use of maximum standard drug therapy.

3. Have given written informed consent, prior to any investigational procedures.

4. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

1. Angle-closure glaucoma

2. Eyes having had previous incisional glaucoma surgery

3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.

4. 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).

5. Any abnormality preventing reliable applanation tonometry of the treated eye.

6. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.

7. Participation in any investigational study within the past 30 days.

8. Inability to perform reliable visual field testing.

9. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.

10. Self-reported poor compliance to treatment.

11. Reluctance to return for scheduled follow-up visits.

12. 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: Prevention

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Rho-Kinase Inhibitor (AR-12286)

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	IOP Reduction	Avoid surgical intervention of glaucoma treatment with use of AR-12286; long lasting effect of study drug to reduce IOP by increase of aqueous outflow	6 Months	Yes
Secondary	Tolerance and Lasting IOP Effect	To evaluate the ocular hypotensive safety (tolerance) of Rho-Kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solution in patients who are avoiding surgical intervention and the long last effect of IOP reduction.	6 Months	Yes