Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Study Identifier
192024-050
CT.gov Identifier
NCT01177098
EudraCT Identifier
2010-021507-24
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Other
  • Ocular Hypertension
    • Study Drug
  • bimatoprost /timolol formulation A fixed combination ophthalmic solution
  • bimatoprost/timolol fixed combination ophthalmic solution
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patient has ocular hypertension or glaucoma in both eyes * Requires IOP-lowering therapy in each eye
    Exclusion Criteria:
    * Active or recurrent eye disease that would interfere with interpretation of study data in either eye * History of any eye surgery or laser in either eye within 6 months * Required chronic use of other eye medications during the study * Anticipated wearing of contact lenses during the study. * Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days

    Protocol Summary

    This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.

    Study Locations

    Location
    Status
    Location
    Artesia, California, United States
    Status
    Not applicable
    Location
    Sydney, New South Wales, Australia
    Status
    Not applicable
    Location
    Brno, Czech Republic
    Status
    Not applicable
    Location
    Leipzig, Germany
    Status
    Not applicable
    Location
    Budapest, Hungary
    Status
    Not applicable
    Location
    Tel Aviv, Israel
    Status
    Not applicable
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