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

Allergan235 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

235

Conditions

Open-angle Glaucoma Ocular Hypertension

Interventions

0.03% Bimatoprost/0.5% Timolol Ophthalmic SolutionDRUG

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 Ophthalmic Solution and 0.5% Timolol Ophthalmic SolutionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4

The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.

Time frame: Baseline, Week 4

Data from ClinicalTrials.gov

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