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

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution
0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

0.03% Bimatoprost/0.5% Timolol in Same Bottle

0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2010
Last Updated
April 9, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01068964
Brief Title
Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2010 (Actual)
Primary Completion Date
September 1, 2010 (Actual)
Study Completion Date
September 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.03% Bimatoprost/0.5% Timolol in Same Bottle
Arm Type
Experimental
Arm Description
Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
Arm Title
0.03% Bimatoprost and 0.5% Timolol in Separate Bottles
Arm Type
Active Comparator
Arm Description
Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution
Other Intervention Name(s)
Bottle 1: Ganfort®
Intervention Description
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
Intervention Name(s)
0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
Other Intervention Name(s)
Bottle 1: Lumigan®, Bottle 2: Timoptol®
Intervention Description
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
Primary Outcome Measure Information:
Title
The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24571886
Citation
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.
Results Reference
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Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

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