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NCT04819269 · ClinicalTrials.gov registry record · Phase 3
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
A Phase 3 study of Dry Eye Disease and Sjögren Syndrome, sponsored by Sylentis, S.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 203
- Enrollment target
- 20
- Study locations
NCT04819269: Completed Phase 3 study of Dry Eye Disease and Sjögren Syndrome, sponsored by Sylentis, S.A..
NCT04819269 is a Phase 3 study of Dry Eye Disease and Sjögren Syndrome that has completed, run by Sylentis, S.A.. The registered enrollment target is 203 participants, below the 249-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04819269, a Phase 3 study of Dry Eye Disease and Sjögren Syndrome, has completed, sponsored by Sylentis, S.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 203 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Tivanisiran sodium ophthalmic solution
- DRUG Vehicle ophthalmic solution
Study Locations (20)
California
- Sylentis Investigative Site - Garden Grove
- Sylentis Investigative Site - Glendale
- Sylentis Investigative Site - Los Angeles
- Sylentis Investigative Site - Newport Beach
- Sylentis Investigative Site - Rancho Cordova
- Sylentis Investigative Site - San Diego
- Sylentis Investigative Site - Torrance
Florida
- Sylentis Investigative Site - Jacksonville
- Sylentis Investigative Site - Largo
- Sylentis Investigative Site - Miami
- Sylentis Investigative Site - Ormond Beach
- Sylentis Investigative Site - Tampa
Colorado
- Sylentis Investigative Site - Aurora
- Sylentis Investigative Site - Colorado Springs
- Sylentis Investigative Site - Littleton
Alabama
- Sylentis Investigative Site - Birmingham
- Sylentis Investigative Site - Dothan
Georgia
- Sylentis Investigative Site - Atlanta
- Sylentis Investigative Site - Morrow
Arizona
- Sylentis Investigative Site - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2023-12-11 |
| Phase | Phase 3 |
What the finished NCT04819269 record still lists
NCT04819269 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 249-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (18% lower).
The record links to 2 conditions, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Tivanisiran sodium ophthalmic solution is the first listed.
NCT04819269 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04819269 about?
NCT04819269 is a clinical study titled "Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome". 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.
What is the current status of trial NCT04819269?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 203 participants. The study started on 2021-05-25. Estimated completion is 2023-12-11.
What conditions does trial NCT04819269 study?
This clinical trial studies the following conditions: Dry Eye Disease, Sjögren Syndrome.
What interventions are being tested in trial NCT04819269?
The interventions under investigation include: Tivanisiran sodium ophthalmic solution (DRUG), Vehicle ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT04819269?
This trial is sponsored by Sylentis, S.A., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04819269 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04819269's enrollment target sits among peer trials
203 16th of 33 higher than 18 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.
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