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

Not Applicable

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution; Drug: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution

• Registration Number: NCT01068964
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-17
• Primary Completion: 2010-09-01
• Study Completion: 2010-09-01
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2011-12-16
• Results First Posted: 2012-01-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.03% Bimatoprost/0.5% Timolol in Same Bottle	0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution	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	0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution	Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution

Primary Outcome Measures

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