Trials / Completed
CompletedNCT02250612
SYL040012, Treatment for Open Angle Glaucoma
A Phase II, Observer Masked, Active Controlled Study of SYL040012 for the Treatment of Elevated Intraocular Pressure in Patients With Open-angle Glaucoma or Ocular Hypertension
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (actual)
- Sponsor
- Sylentis, S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 1 drop of 0.375% SYL040012 (bamosiran) | |
| DRUG | 1 drop of 0.750% SYL040012 (bamosiran) | |
| DRUG | 1 drop of 1.125% SYL040012 (bamosiran) | |
| DRUG | 1 drop of 1.5% SYL040012 (bamosiran) | |
| DRUG | 1 drop of 0.5 % timolol maleate |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-08-01
- Completion
- 2016-01-01
- First posted
- 2014-09-26
- Last updated
- 2021-01-06
- Results posted
- 2020-11-04
Locations
21 sites across 4 countries: United States, Estonia, Germany, Spain
Source: ClinicalTrials.gov record NCT02250612. Inclusion in this directory is not an endorsement.