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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-01

Study Completion Date

2012-02-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

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

Group Type ACTIVE_COMPARATOR

bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

Intervention Type DRUG

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

latanoprost 0.005% ophthalmic solution

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

Group Type ACTIVE_COMPARATOR

latanoprost 0.005% ophthalmic solution

Intervention Type DRUG

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

Interventions

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bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

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

Intervention Type DRUG

latanoprost 0.005% ophthalmic solution

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

Intervention Type DRUG

Other Intervention Names

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GANFort® Xalatan®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No