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

Allergan

Status and phase: Terminated; Phase 4

Conditions: Glaucoma, Angle-Closure

Treatments: Drug: latanoprost; Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151904

MA-COM004

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

COMBIGAN® with Latanoprost

Experimental group

Description:

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.

Treatment:

Drug: brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution

Drug: latanoprost