Trials / Active Not Recruiting
Active Not RecruitingNCT03891446
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 455 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bimatoprost SR | Intraocular implant |
| OTHER | Standard of Care | Standard of care treatment based on investigator's judgement. |
Timeline
- Start date
- 2019-03-27
- Primary completion
- 2026-07-01
- Completion
- 2026-08-01
- First posted
- 2019-03-27
- Last updated
- 2025-08-28
Locations
124 sites across 26 countries: United States, 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03891446. Inclusion in this directory is not an endorsement.