Back to resultsSafety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
latanoprost 0.005% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary open-angle glaucoma that has never been treated
- Visual Acuity 20/60 or better in each eye
Exclusion Criteria:
- Eye surgery within 3 months
- Any refractive eye surgery
- Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
- Eye inflammation or eye infection within 3 months
- Eye trauma within 6 months
- Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
latanoprost 0.005% ophthalmic solution
Arm Description
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Outcomes
Primary Outcome Measures
Change From Baseline in Average Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
Secondary Outcome Measures
Change From Baseline IOP
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
Percentage of Patients Reaching a Predefined Target Pressure Threshold
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01243567
Brief Title
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2010 (Actual)
Primary Completion Date
February 14, 2012 (Actual)
Study Completion Date
February 14, 2012 (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 study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Arm Type
Active Comparator
Arm Description
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Arm Title
latanoprost 0.005% ophthalmic solution
Arm Type
Active Comparator
Arm Description
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
Other Intervention Name(s)
GANFort®
Intervention Description
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% ophthalmic solution
Other Intervention Name(s)
Xalatan®
Intervention Description
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
Time Frame
Baseline, Month 3
Secondary Outcome Measure Information:
Title
Change From Baseline IOP
Description
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
Time Frame
Baseline, Month 3
Title
Percentage of Patients Reaching a Predefined Target Pressure Threshold
Description
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
Time Frame
Baseline, Month 3
Title
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Description
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Time Frame
Baseline, Month 3
Title
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Description
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Time Frame
Baseline, Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary open-angle glaucoma that has never been treated
Visual Acuity 20/60 or better in each eye
Exclusion Criteria:
Eye surgery within 3 months
Any refractive eye surgery
Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
Eye inflammation or eye infection within 3 months
Eye trauma within 6 months
Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Coimbra
Country
Portugal
City
Madrid
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24748767
Citation
Gutierrez-Diaz E, Silva Cotta J, Munoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naive glaucoma patients at high risk of progression: a pilot study. Clin Ophthalmol. 2014 Apr 10;8:725-32. doi: 10.2147/OPTH.S56735. eCollection 2014.
Results Reference
background
Learn more about this trial
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
We'll reach out to this number within 24 hrs