Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Last updated: February 16, 2024
Sponsor: Sylentis, S.A.
Overall Status: Completed

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Dry Eyes

Sjogren's Syndrome

Treatment

Tivanisiran sodium ophthalmic solution

Vehicle ophthalmic solution

Clinical Study ID

NCT04819269
SYL1001_V
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 duringthe 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

Exclusion Criteria:

  • Any concomitant treatment or prior ocular procedure or surgery, or alteration of thedose 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 Design

Total Participants: 203
Treatment Group(s): 2
Primary Treatment: Tivanisiran sodium ophthalmic solution
Phase: 3
Study Start date:
May 25, 2021
Estimated Completion Date:
December 11, 2023

Connect with a study center

  • Sylentis Investigative Site

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Sylentis Investigative Site

    Barcelona, 08022
    Spain

    Site Not Available

  • Sylentis Investigative Site

    Madrid, 28040
    Spain

    Site Not Available

  • Sylentis Investigative Site

    Sevilla, 41009
    Spain

    Site Not Available

  • Sylentis Investigative Sites

    Valladolid, 47003
    Spain

    Site Not Available

  • Sylentis Investigative Site

    Zaragoza, 50004
    Spain

    Site Not Available

  • Sylentis Investigative Site

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Sylentis Investigative Site

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Sylentis Investigative Site

    Scottsdale, Arizona 85254
    United States

    Site Not Available

  • Sylentis Investigative Site

    Garden Grove, California 92843
    United States

    Site Not Available

  • Sylentis Investigative Site

    Glendale, California 91204
    United States

    Site Not Available

  • Sylentis Investigative Site

    Los Angeles, California 90013
    United States

    Site Not Available

  • Sylentis Investigative Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • Sylentis Investigative Site

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Sylentis Investigative Site

    San Diego, California 92122
    United States

    Site Not Available

  • Sylentis Investigative Site

    Torrance, California 90505
    United States

    Site Not Available

  • Sylentis Investigative Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Sylentis Investigative Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Sylentis Investigative Site

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Sylentis Investigative Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Sylentis Investigative Site

    Largo, Florida 33773
    United States

    Site Not Available

  • Sylentis Investigative Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Sylentis Investigative Site

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Sylentis Investigative Site

    Tampa, Florida 33603
    United States

    Site Not Available

  • Sylentis Investigative Site

    Atlanta, Georgia 30339
    United States

    Site Not Available

  • Sylentis Investigative Site

    Morrow, Georgia 30260
    United States

    Site Not Available

  • Sylentis Investigative Site

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Sylentis Investigative Site

    Louisville, Kentucky 40220
    United States

    Site Not Available

  • Sylentis Investigative Site

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Sylentis Investigative Site

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Sylentis Investigative Site

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Sylentis Investigative Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Sylentis Investigative Site

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Sylentis Investigative Site

    Washington, Missouri 63090
    United States

    Site Not Available

  • Sylentis Investigative Site

    Slingerlands, New York 12159
    United States

    Site Not Available

  • Sylentis Investigative Site

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Sylentis Investigative Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Sylentis Investigative Site

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Sylentis Investigative Site

    Cleveland, Ohio 44115
    United States

    Site Not Available

  • Sylentis Investigative Site

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Sylentis Investigative Site

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Sylentis Investigative Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Sylentis Investigative Site

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Sylentis Investigative Site

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Sylentis Investigative Site

    El Paso, Texas 79902
    United States

    Site Not Available

  • Sylentis Investigative Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Sylentis Investigative Site

    Falls Church, Virginia 22042
    United States

    Site Not Available

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