Long-term Safety and Efficacy Extension Trial of Bimatoprost SR (Maia)
Status and phase
Invitation-only
Phase 3
Conditions
Open-Angle Glaucoma
Ocular Hypertension
Treatments
Drug: Bimatoprost SR
Other: Standard of Care
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
600 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
600 participants in 4 patient groups
Lead-in study 192024-091 or -092 or -095
Experimental group
Description:
Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered.
Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Treatment:
Other: Standard of Care
Lead-in study 192024-093 Stage 1
Experimental group
Description:
Participants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations.
Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered.
Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Treatment:
Other: Standard of Care
Lead-in study 192024-093 Stage 2
Experimental group
Description:
Participants who received 1 Bimatoprost administration due to sustained efficacy:
Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.
Treatment:
Other: Standard of Care
Drug: Bimatoprost SR
Lead-in study ARGOS
Experimental group
Description:
Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration.
Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration.
Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.
Treatment:
Other: Standard of Care
Drug: Bimatoprost SR
Trial contacts and locations
124
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Data sourced from clinicaltrials.gov
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