Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
NCT ID: NCT01547598
Last Updated: 2014-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
135 participants
INTERVENTIONAL
2011-12-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LUMIGAN® RC
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.
travoprost ophthalmic solution 0.004%
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
Bimatoprost ophthalmic solution 0.01%
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
DuoTrav®
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.
travoprost ophthalmic solution 0.004%
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
travoprost 0.004% / timolol 0.5% combination ophthalmic solution
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.
Interventions
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travoprost ophthalmic solution 0.004%
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
travoprost 0.004% / timolol 0.5% combination ophthalmic solution
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.
Bimatoprost ophthalmic solution 0.01%
LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity of 20/100 or better in both eyes
Exclusion Criteria
* Previous treatment with LUMIGAN® RC or DuoTrav®
* History of LASIK, LASEK, RK or PRK in the study eye(s)
* Active ocular inflammation
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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GMA-LUM-11-020
Identifier Type: -
Identifier Source: org_study_id
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