Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

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

  • Spain
      • Barcelona, Spain, 08022
        • Sylentis Investigative Site
      • Madrid, Spain, 28034
        • Sylentis Investigative Site
      • Madrid, Spain, 28040
        • Sylentis Investigative Site
      • Sevilla, Spain, 41009
        • Sylentis Investigative Site
      • Valladolid, Spain, 47003
        • Sylentis Investigative Sites
      • Zaragoza, Spain, 50004
        • Sylentis Investigative Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Sylentis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Sylentis Investigative Site
      • Dothan, Alabama, United States, 36301
        • Sylentis Investigative Site
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Sylentis Investigative Site
    • California
      • Garden Grove, California, United States, 92843
        • Sylentis Investigative Site
      • Glendale, California, United States, 91204
        • Sylentis Investigative Site
      • Los Angeles, California, United States, 90013
        • Sylentis Investigative Site
      • Newport Beach, California, United States, 92663
        • Sylentis Investigative Site
      • Rancho Cordova, California, United States, 95670
        • Sylentis Investigative Site
      • San Diego, California, United States, 92122
        • Sylentis Investigative Site
      • Torrance, California, United States, 90505
        • Sylentis Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Sylentis Investigative Site
      • Colorado Springs, Colorado, United States, 80907
        • Sylentis Investigative Site
      • Littleton, Colorado, United States, 80120
        • Sylentis Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Sylentis Investigative Site
      • Largo, Florida, United States, 33773
        • Sylentis Investigative Site
      • Miami, Florida, United States, 33136
        • Sylentis Investigative Site
      • Ormond Beach, Florida, United States, 32174
        • Sylentis Investigative Site
      • Tampa, Florida, United States, 33603
        • Sylentis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Sylentis Investigative Site
      • Morrow, Georgia, United States, 30260
        • Sylentis Investigative Site
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Sylentis Investigative Site
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Sylentis Investigative Site
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Sylentis Investigative Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Sylentis Investigative Site
      • Saint Louis, Missouri, United States, 63131
        • Sylentis Investigative Site
      • Washington, Missouri, United States, 63090
        • Sylentis Investigative Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Sylentis Investigative Site
      • High Point, North Carolina, United States, 27262
        • Sylentis Investigative Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Sylentis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • Sylentis Investigative Site
      • Columbus, Ohio, United States, 43215
        • 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, 38103
        • Sylentis Investigative Site
      • Nashville, Tennessee, United States, 37215
        • Sylentis Investigative Site
    • Texas
      • El Paso, Texas, United States, 79902
        • Sylentis Investigative Site
      • Houston, Texas, United States, 77030
        • Sylentis Investigative Site
      • Houston, Texas, United States, 77034
        • Sylentis Investigative Site
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • 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:

  • Subject is a male or a female aged ≥ 18 years
  • 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
  • Willing to not use AT or autologous serum for the study duration
  • VAS scale for Dry Eye Symptom Score ≥ 40
  • Total CFS ≥ 5
  • Schirmer's test with anesthesia < 10 mm/5min
  • Patients with Sjögren Syndrome

Exclusion Criteria:

  • Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
  • Use of contact lenses during the study
  • Significant Eye diseases according to investigator's opinion

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: Double

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
Active Comparator: 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
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
Time Frame: 85 days
85 days
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
Time Frame: 85 days
85 days

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)

May 25, 2021

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 26, 2021

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_V

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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