Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-01

Study Completion Date

2010-09-01

Brief Summary

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This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension

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Detailed Description

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Conditions

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Open-angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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0.03% Bimatoprost/0.5% Timolol in Same Bottle

Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution

Group Type EXPERIMENTAL

0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution

Intervention Type DRUG

One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution

0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Group Type ACTIVE_COMPARATOR

0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution

Intervention Type DRUG

One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Interventions

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0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution

One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution

Intervention Type DRUG

0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution

One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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Bottle 1: Ganfort® Bottle 1: Lumigan® Bottle 2: Timoptol®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of open-angle glaucoma or ocular hypertension in one or both eyes
* Eye pressure lowering topical medications are not working
* Visual acuity is at least 0.2 in each eye

Exclusion Criteria

* Uncontrolled systemic disease
* Any other active eye disease other than glaucoma or ocular hypertension
* Significant visual field loss or evidence of progressive visual field loss within the last year
* Anticipated wearing of contact lenses during the study
* Required chronic use of other ocular medications during the study
* Eye surgery or laser treatment within 12 weeks prior to study enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No