Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

Allergan

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: Drug: travoprost ophthalmic solution 0.004%; Drug: Bimatoprost ophthalmic solution 0.01%; Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547598

GMA-LUM-11-020

Details and patient eligibility

About

This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open angle glaucoma or ocular hypertension
• Best corrected visual acuity of 20/100 or better in both eyes

Exclusion criteria

• Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
• Previous treatment with LUMIGAN® RC or DuoTrav®
• History of LASIK, LASEK, RK or PRK in the study eye(s)
• Active ocular inflammation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups

LUMIGAN® RC

Active Comparator group

Description:

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.

Treatment:

Drug: Bimatoprost ophthalmic solution 0.01%

Drug: travoprost ophthalmic solution 0.004%

DuoTrav®

Active Comparator group

Description:

Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.

Treatment:

Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution

Drug: travoprost ophthalmic solution 0.004%