Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Study Identifier
1698-302-007
CT.gov Identifier
NCT03891446
EudraCT Identifier
2018-003597-26
EUCTIS ID
2023-504601-36-00
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Glaucoma - Open Angle
  • Ocular Hypertension
    • Study Drug
  • Bimatoprost SR
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR. * Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.
    Exclusion Criteria:
    * Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study. * Concurrent or anticipated enrollment in another investigational drug or device study during the present study. * Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study. * Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092. * For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

    Protocol Summary

    This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

    Study Locations

    Location
    Status
    Location
    Trinity Research Group /ID# 240190
    Dothan, Alabama, United States, 36301
    Status
    Not applicable
    Location
    Arizona Eye Center - West Ray Road /ID# 240239
    Chandler, Arizona, United States, 85224
    Status
    Not applicable
    Location
    Arizona Glaucoma Specialists /ID# 240212
    Phoenix, Arizona, United States, 85050-4265
    Status
    Not applicable
    Location
    M&M Eye Institute /ID# 240236
    Prescott, Arizona, United States, 86301
    Status
    Not applicable
    Location
    Horizon Eye Specialists & Lasik Centers /ID# 240255
    Sun City, Arizona, United States, 85351
    Status
    Not applicable
    Location
    Angeles Eye Institute /ID# 250397
    Culver City, California, United States, 90232
    Status
    Not applicable
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