Back to resultsAn Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
bimatoprost 0.01%
travatan 0.004%
timolol 0.5%
hypromellose 0.3%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Ocular hypertension or glaucoma that requires treatment with medication
- Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes
Exclusion Criteria:
- History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
- History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
- Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bimatoprost 0.01% and hypromellose 0.3%
travatan 0.004% and timolol 0.5%
Arm Description
Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01881126
Brief Title
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost 0.01% and hypromellose 0.3%
Arm Type
Active Comparator
Arm Description
Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
Arm Title
travatan 0.004% and timolol 0.5%
Arm Type
Active Comparator
Arm Description
Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.01%
Other Intervention Name(s)
Lumigan® RC, Lumigan®
Intervention Description
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
travatan 0.004%
Other Intervention Name(s)
Travatan Z®
Intervention Description
Travatan 0.004% administered to both eyes once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
timolol 0.5%
Other Intervention Name(s)
Timolol Maleate-EX, Timolol GFS
Intervention Description
Timolol 0.5% administered to both eyes once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
hypromellose 0.3%
Other Intervention Name(s)
GenTeal®
Intervention Description
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
Description
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
Time Frame
Week 12 at 8 AM, 12 PM, and 4 PM
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular hypertension or glaucoma that requires treatment with medication
Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes
Exclusion Criteria:
History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Barrie
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
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