Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Open-Angle Glaucoma, Ocular Hypertension, Bimatoprost, DURYSTA
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.
Interventions
DRUGBimatoprost SR
Intraocular implant
OTHERStandard of Care
Standard of care treatment based on investigator's judgement.
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of effect of Bimatoprost SR | Approximately 24 months | Retreatment or rescue administered for IOP lowering, determined by the investigator. |
| Number of patients experiencing a treatment emergent adverse event | Approximately 24 months | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. |
Countries
Argentina, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Egypt, France, Germany, Hong Kong, Israel, Italy, New Zealand, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed