Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
Primary Purpose
Ocular Hypertension, Glaucoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bimatoprost 0.03% eye drops
latanoprost 0.005% eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
- Ocular hypertension or chronic glaucoma
- Patient requires IOP-lowering therapy in both eyes
Exclusion Criteria:
- Uncontrolled medical conditions
- Hypersensitivity to study medications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
bimatoprost 0.03% eye drops
latanoprost 0.005% eye drops
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00541242
Brief Title
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
bimatoprost 0.03% eye drops
Arm Title
2
Arm Type
Active Comparator
Arm Description
latanoprost 0.005% eye drops
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03% eye drops
Other Intervention Name(s)
latanoprost = Xalatan®, bimatoprost = Lumigan®
Intervention Description
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% eye drops
Other Intervention Name(s)
Xalatan®
Intervention Description
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Description
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Description
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Time Frame
Baseline, Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ocular hypertension or chronic glaucoma
Patient requires IOP-lowering therapy in both eyes
Exclusion Criteria:
Uncontrolled medical conditions
Hypersensitivity to study medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
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