Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Sponsored by AbbVie
About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 6 years ago
What is this trial about?
What are the participation requirements?
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.