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NCT05310422 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Tivanisiran to Treat Dry Eye
A Phase 3 study of Dry Eye Disease, sponsored by Sylentis, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT05310422: Completed Phase 3 study of Dry Eye Disease, sponsored by Sylentis, S.A..
NCT05310422 is a Phase 3 study of Dry Eye Disease that has completed, run by Sylentis, S.A.. The registered enrollment target is 301 participants, above the 246-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05310422, a Phase 3 study of Dry Eye Disease, has completed, sponsored by Sylentis, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).
Conditions Studied
Interventions
- DRUG Tivanisiran sodium ophthalmic solution
- DRUG Vehicle ophthalmic solution
Study Locations (20)
California
- FYDES Investigative Site - Glendale
- Sylentis Investigative Site - Hemet
- Sylentis Investigative Site - Los Angeles
- Sylentis Investigative Site - Murrieta
- Sylentis Investigative Site - Newport Beach
Florida
- FYDES Investigative Site - Delray Beach
- FYDES Investigative Site - Jacksonville
- Sylentis Investigative Site - Largo
Missouri
- Sylentis Investigative Site - Kansas City
- FYDES Investigative Site - St Louis
- Sylentis Investigative Site - Washington
Arizona
- Sylentis Investigative Site - Chandler
- Sylentis Investigative Site - Phoenix
North Carolina
- Sylentis Investigative Site - Asheville
- Sylentis Investigative Site - Garner
Georgia
- Sylentis Investigative Site - Morrow
Michigan
- Sylentis Investigative Site - Fraser
New York
- Sylentis Investigative Site - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2022-03-24 |
| Est. Completion | 2023-10-11 |
| Phase | Phase 3 |
What the finished NCT05310422 record still lists
NCT05310422 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, above the 246-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Tivanisiran sodium ophthalmic solution is the first listed.
NCT05310422 names 20 study sites across 10 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT05310422 about?
NCT05310422 is a clinical study titled "Safety Study of Tivanisiran to Treat Dry Eye". This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).
What is the current status of trial NCT05310422?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2022-03-24. Estimated completion is 2023-10-11.
What conditions does trial NCT05310422 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT05310422?
The interventions under investigation include: Tivanisiran sodium ophthalmic solution (DRUG), Vehicle ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05310422?
This trial is sponsored by Sylentis, S.A., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05310422 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05310422's enrollment target sits among peer trials
301 10th of 33 higher than 24 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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