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COMPLETED Phase 3

Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

NCT04819269 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 203 participants
Start Date 2021-05-25
Est. Completion 2023-12-11
Phase Phase 3

Sponsor

Sylentis, S.A.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04819269

The ClinicalTrials.gov registry entry for NCT04819269 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 203 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sylentis, S.A., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04819269 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04819269?

The interventions under investigation include: Tivanisiran sodium ophthalmic solution (DRUG), Vehicle ophthalmic solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04819269?

This trial is sponsored by Sylentis, S.A., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial