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
This trial is active, not recruiting.
|Conditions||glaucoma, ocular hypertension|
|Treatments||bimatoprost 0.01%, travoprost 0.004%, timolol 0.5%, hypromellose 0.3%|
|Start date||April 2014|
|End date||November 2015|
|Trial size||100 participants|
|Trial identifier||NCT02097719, GMA-LUM-12-022|
This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Intraocular Pressure (IOP) in the Study Eye
time frame: Month 3
Male or female participants at least 18 years old.
Inclusion Criteria: - Ocular hypertension or glaucoma that requires treatment with medication - Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes Exclusion Criteria: - History of LASIK, LASEK, RK, and/or PRK in the study eye(s) - History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months - Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
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