Safety Study of Tivanisiran to Treat Dry Eye (FYDES)

February 16, 2024 updated by: Sylentis, S.A.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85021
        • Sylentis Investigative Site
      • Phoenix, Arizona, United States, 85032
        • Sylentis Investigative Site
    • California
      • Glendale, California, United States, 91204
        • FYDES Investigative Site
      • Hemet, California, United States, 92545
        • Sylentis Investigative Site
      • Los Angeles, California, United States, 85032
        • Sylentis Investigative Site
      • Murrieta, California, United States, 92562
        • Sylentis Investigative Site
      • Newport Beach, California, United States, 92663
        • Sylentis Investigative Site
    • Florida
      • Delray Beach, Florida, United States, 33484
        • FYDES Investigative Site
      • Jacksonville, Florida, United States, 32256
        • FYDES Investigative Site
      • Largo, Florida, United States, 33773
        • Sylentis Investigative Site
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Sylentis Investigative Site
    • Michigan
      • Fraser, Michigan, United States, 48026
        • Sylentis Investigative Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Sylentis Investigative Site
      • Saint Louis, Missouri, United States, 63131
        • FYDES Investigative Site
      • Washington, Missouri, United States, 63090
        • Sylentis Investigative Site
    • New York
      • Rochester, New York, United States, 14618
        • Sylentis Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Sylentis Investigative Site
      • Garner, North Carolina, United States, 27529
        • Sylentis Investigative Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Sylentis Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Sylentis Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Sylentis Investigative Site
    • Texas
      • Austin, Texas, United States, 78731
        • Sylentis Investigative Site
      • El Paso, Texas, United States, 79902
        • FYDES Investigative Site
      • San Antonio, Texas, United States, 78215
        • Sylentis Investigative Site
      • San Antonio, Texas, United States, 78230
        • Sylentis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be at least 18 years of age
  • Have given their written consent to participate in the study
  • Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection

Exclusion Criteria:

  • Pregnant or breast feeding females with a postitive pregnancy test
  • Women of childbearing potential not willing to use a medically acceptable contraceptive method
  • Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
  • Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
  • Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle ophthalmic solution
Drug: Vehicle ophthalmic solution
1 drop in the affected eye(s) once daily
Experimental: Tivanisiran sodium ophthalmic solution
Drug: Tivanisiran sodium ophthalmic solution
1 drop in the affected eye(s) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sylentis, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYL1001_VI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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