Trials / Completed
CompletedNCT04819269
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Sylentis, S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tivanisiran sodium ophthalmic solution | 1 drop in the affected eye(s) once daily |
| DRUG | Vehicle ophthalmic solution | 1 drop in the affected eye(s) once daily |
Timeline
- Start date
- 2021-05-25
- Primary completion
- 2023-12-11
- Completion
- 2023-12-11
- First posted
- 2021-03-26
- Last updated
- 2024-02-20
Locations
46 sites across 2 countries: United States, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04819269. Inclusion in this directory is not an endorsement.