Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

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

Enrolling by invitation
Open-Angle Glaucoma
Ocular Hypertension
600 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
None (Open Label)

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
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Eligibility criteria

Participant attributes:
Male and Female


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

- 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.

All the cities where the clinical studies are located

Halifax - B3H 3A7
Mississauga - L4W 1W9

Nova Scotia