Back to resultsSafety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
travoprost ophthalmic solution 0.004%
travoprost 0.004% / timolol 0.5% combination ophthalmic solution
Bimatoprost ophthalmic solution 0.01%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Open angle glaucoma or ocular hypertension
- Best corrected visual acuity of 20/100 or better in both eyes
Exclusion Criteria:
- Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
- Previous treatment with LUMIGAN® RC or DuoTrav®
- History of LASIK, LASEK, RK or PRK in the study eye(s)
- Active ocular inflammation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LUMIGAN® RC
DuoTrav®
Arm Description
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Outcomes
Primary Outcome Measures
Mean Diurnal Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Secondary Outcome Measures
Change From Baseline in Mean IOP at Week 12
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Change From Baseline in Mean IOP at Week 6
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01547598
Brief Title
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (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 non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LUMIGAN® RC
Arm Type
Active Comparator
Arm Description
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Arm Title
DuoTrav®
Arm Type
Active Comparator
Arm Description
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
travoprost ophthalmic solution 0.004%
Other Intervention Name(s)
Travatan® Z
Intervention Description
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
travoprost 0.004% / timolol 0.5% combination ophthalmic solution
Other Intervention Name(s)
DuoTrav®
Intervention Description
DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost ophthalmic solution 0.01%
Other Intervention Name(s)
LUMIGAN® RC
Intervention Description
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Primary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean IOP at Week 12
Description
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
Description
IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time Frame
Baseline, Week 12
Title
Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
Description
IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time Frame
Week 12
Title
Change From Baseline in Mean IOP at Week 6
Description
IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Open angle glaucoma or ocular hypertension
Best corrected visual acuity of 20/100 or better in both eyes
Exclusion Criteria:
Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
Previous treatment with LUMIGAN® RC or DuoTrav®
History of LASIK, LASEK, RK or PRK in the study eye(s)
Active ocular inflammation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
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