Trials / Completed
CompletedNCT02247804
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension
The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 594 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bimatoprost SR | Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32. |
| DRUG | Active Comparator: Timolol 0.5% | Timolol 0.5% administered once in the morning and once in the evening for up to 20 months. |
| OTHER | Sham: Applicator Without Needle | Sham administered on Day 1, Week 16, and Week 32. |
| DRUG | Timolol Vehicle (placebo) | Timolol vehicle administered once in the morning and once in the evening for up to 20 months. |
Timeline
- Start date
- 2014-12-15
- Primary completion
- 2018-02-19
- Completion
- 2019-07-19
- First posted
- 2014-09-25
- Last updated
- 2020-06-11
- Results posted
- 2020-04-24
Locations
106 sites across 14 countries: United States, Australia, Austria, Belgium, Brazil, Denmark, Hong Kong, Hungary, Israel, Peru, Philippines, Poland, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02247804. Inclusion in this directory is not an endorsement.