Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

Study Identifier
192024-041D
CT.gov Identifier
NCT01157364
EudraCT Identifier
2011-005091-42
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Open Angle
  • Ocular Hypertension
    • Study Drug
  • bimatoprost 20 µg generation 2
  • bimatoprost 15 µg generation 2
  • bimatoprost 10 µg generation 2
  • bimatoprost 6 µg generation 2
  • bimatoprost 15 µg generation 1
  • bimatoprost 10 µg generation 1
  • bimatoprost 0.03%
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of open angle glaucoma or ocular hypertension
    Exclusion Criteria:
    * Uncontrolled medical conditions * Anticipated wearing of contact lenses during the study

    Protocol Summary

    This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

    Study Locations

    Location
    Status
    Location
    Sall Research Medical Center
    Artesia, California, United States, 90701
    Status
    Not applicable
    Location
    Shiley Eye Center, Hamilton Glaucoma Center, University of California, San Diego
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Doheny Eye Institute
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    Martel Eye Medical Group
    Rancho Cordova, California, United States, 95670
    Status
    Not applicable
    Location
    Shasta Eye Medical Group, Inc.
    Redding, California, United States, 96002
    Status
    Not applicable
    Location
    Grutzmacher and Lewis, Inc.
    Sacramento, California, United States, 95815
    Status
    Not applicable
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