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
NCT01881126 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 93
Last updated 2015-11-30
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.
Conditions
Interventions
- DRUG
-
bimatoprost 0.01%
Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
- DRUG
-
travatan 0.004%
Travatan 0.004% administered to both eyes once daily for 12 weeks.
- DRUG
-
timolol 0.5%
Timolol 0.5% administered to both eyes once daily for 12 weeks.
- DRUG
-
hypromellose 0.3%
Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Medical Director · Allergan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
Countries
- Canada
Study Locations
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