Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

Study Identifier
MAF-AGN-OPH-GLA-010
CT.gov Identifier
NCT01243567
EudraCT Identifier
2009-012799-28
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Open Angle
    • Study Drug
  • bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution
  • latanoprost 0.005% ophthalmic solution
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18 - 85 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of primary open-angle glaucoma that has never been treated * Visual Acuity 20/60 or better in each eye
    Exclusion Criteria:
    * Eye surgery within 3 months * Any refractive eye surgery * Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \[COPD\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \[heart attack\]) * Eye inflammation or eye infection within 3 months * Eye trauma within 6 months * Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study

    Protocol Summary

    This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.

    Study Locations

    Location
    Status
    Location
    Coimbra, Portugal
    Status
    Not applicable
    Location
    Madrid, Spain
    Status
    Not applicable