NCT03891446

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

Status:
Enrolling by invitation
Enrollment:
600 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
1698-302-007
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

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.

All the cities where the clinical studies are located

Halifax - B3H 3A7

Nova Scotia

Ontario

More information about this study

clinicaltrials.gov