Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma, Open-Angle

Treatments: Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution; Drug: latanoprost 0.005% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243567

MAF-AGN-OPH-GLA-010

2009-012799-28 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.

Enrollment: 81 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary open-angle glaucoma that has never been treated
• Visual Acuity 20/60 or better in each eye

Exclusion criteria

• Eye surgery within 3 months
• Any refractive eye surgery
• Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
• Eye inflammation or eye infection within 3 months
• Eye trauma within 6 months
• Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 2 patient groups

bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

Active Comparator group

Description:

Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Treatment:

Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

latanoprost 0.005% ophthalmic solution

Active Comparator group

Description:

Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Treatment:

Drug: latanoprost 0.005% ophthalmic solution