MAIA
Brief 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.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
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.
