Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients

NCT ID: NCT01151904

Last Updated: 2013-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-02-29

Brief Summary

This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.

Conditions

Glaucoma, Angle-Closure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COMBIGAN® with Latanoprost

Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.

Group Type: EXPERIMENTAL

brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution

Intervention Type: DRUG

COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.

latanoprost

Intervention Type: DRUG

Latanoprost administered in the affected eye(s) as prescribed by physician.

Interventions

brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution

COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.

Intervention Type: DRUG

latanoprost

Latanoprost administered in the affected eye(s) as prescribed by physician.

Intervention Type: DRUG

Other Intervention Names

COMBIGAN®

Eligibility Criteria

Inclusion Criteria

• Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
• Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
• Diagnosis of chronic angle-closure glaucoma
• Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Exclusion Criteria

• Known allergy or hypersensitivity to COMBIGAN®
• Corneal abnormalities that would preclude accurate IOP readings
• Any other active ocular disease other than glaucoma or ocular hypertension
• Ocular surgery within the past 3 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

MA-COM004

Identifier Type: -

Identifier Source: org_study_id