Efficacy and Safety of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Identifier
192024-092
CT.gov Identifier
NCT02250651
EudraCT Identifier
2014-003186-24
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, Czech, Italian, Spanish, Turkish, Zulu
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Study Details

Medical Condition
  • Glaucoma - Open Angle
  • Ocular Hypertension
    • Study Drug
  • Bimatoprost SR
  • Active Comparator: Timolol 0.5%
  • Timolol Vehicle (placebo)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.
    Exclusion Criteria:
    * Previous enrollment in another Allergan Bimatoprost SR Study * Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye * Anticipated need for laser eye surgery within the first 52 weeks of the study duration * History of glaucoma surgery

    Protocol Summary

    This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

    Study Locations

    Location
    Status
    Location
    Eye Center South
    Dothan, Alabama, United States, 36301
    Status
    Not applicable
    Location
    Arizona Eye Center
    Chandler, Arizona, United States, 85224
    Status
    Not applicable
    Location
    Vold Vision
    Fayetteville, Arkansas, United States, 72704
    Status
    Not applicable
    Location
    Mark B. Kislinger, MD, Inc.
    Glendora, California, United States, 91741
    Status
    Not applicable
    Location
    Inland Eye Specialists
    Hemet, California, United States, 92545
    Status
    Not applicable
    Location
    Southern California Eye Physicians and Surgeons
    Los Alamitos, California, United States, 90720
    Status
    Not applicable
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