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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.03% Bimatoprost/0.5% Timolol in Same Bottle; Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	Drug: 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; Other Names: Bottle 1: Ganfort®
Active Comparator: 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles; Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution	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; Other Names: Bottle 1: Lumigan®; Bottle 2: Timoptol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Ling Z, Zhang M, Hu Y, Yin Z, Xing Y, Fang A, Ye J, Chen X, Liu D, Wang Y, Sun W, Dong Y, Sun X. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J (Engl). 2014;127(5):905-10.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions; Bimatoprost
• Other Study ID Numbers: 192024-052