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Completed
NCT03891446
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 455
Sponsor: AbbVie
Location: Trinity Research Group /ID# 240190 Dothan Alabama
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT03891446). StuddyBuddy aggregates publicly available trial information.