Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
NCT ID: NCT04819269
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
203 participants
INTERVENTIONAL
2021-05-25
2023-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tivanisiran sodium ophthalmic solution
Tivanisiran sodium ophthalmic solution
1 drop in the affected eye(s) once daily
Vehicle ophthalmic solution
Vehicle ophthalmic solution
1 drop in the affected eye(s) once daily
Interventions
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Tivanisiran sodium ophthalmic solution
1 drop in the affected eye(s) once daily
Vehicle ophthalmic solution
1 drop in the affected eye(s) once daily
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of contact lenses during the study
* Significant Eye diseases according to investigator's opinion
18 Years
ALL
No
Sponsors
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Sylentis, S.A.
INDUSTRY
Responsible Party
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Locations
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Sylentis Investigative Site
Birmingham, Alabama, United States
Sylentis Investigative Site
Dothan, Alabama, United States
Sylentis Investigative Site
Scottsdale, Arizona, United States
Sylentis Investigative Site
Garden Grove, California, United States
Sylentis Investigative Site
Glendale, California, United States
Sylentis Investigative Site
Los Angeles, California, United States
Sylentis Investigative Site
Newport Beach, California, United States
Sylentis Investigative Site
Rancho Cordova, California, United States
Sylentis Investigative Site
San Diego, California, United States
Sylentis Investigative Site
Torrance, California, United States
Sylentis Investigative Site
Aurora, Colorado, United States
Sylentis Investigative Site
Colorado Springs, Colorado, United States
Sylentis Investigative Site
Littleton, Colorado, United States
Sylentis Investigative Site
Jacksonville, Florida, United States
Sylentis Investigative Site
Largo, Florida, United States
Sylentis Investigative Site
Miami, Florida, United States
Sylentis Investigative Site
Ormond Beach, Florida, United States
Sylentis Investigative Site
Tampa, Florida, United States
Sylentis Investigative Site
Atlanta, Georgia, United States
Sylentis Investigative Site
Morrow, Georgia, United States
Sylentis Investigative Site
Carmel, Indiana, United States
Sylentis Investigative Site
Waltham, Massachusetts, United States
Sylentis Investigative Site
Ypsilanti, Michigan, United States
Sylentis Investigative Site
Kansas City, Missouri, United States
Sylentis Investigative Site
St Louis, Missouri, United States
Sylentis Investigative Site
Washington, Missouri, United States
Sylentis Investigative Site
Asheville, North Carolina, United States
Sylentis Investigative Site
High Point, North Carolina, United States
Sylentis Investigative Site
Fargo, North Dakota, United States
Sylentis Investigative Site
Cleveland, Ohio, United States
Sylentis Investigative Site
Columbus, Ohio, United States
Sylentis Investigative Site
Cranberry Township, Pennsylvania, United States
Sylentis Investigative Site
Rapid City, South Dakota, United States
Sylentis Investigative Site
Memphis, Tennessee, United States
Sylentis Investigative Site
Nashville, Tennessee, United States
Sylentis Investigative Site
El Paso, Texas, United States
Sylentis Investigative Site
Houston, Texas, United States
Sylentis Investigative Site
Houston, Texas, United States
Sylentis Investigative Site
Falls Church, Virginia, United States
Sylentis Investigative Site
Pamplona, Navarre, Spain
Sylentis Investigative Site
Barcelona, , Spain
Sylentis Investigative Site
Madrid, , Spain
Sylentis Investigative Site
Madrid, , Spain
Sylentis Investigative Site
Seville, , Spain
Sylentis Investigative Sites
Valladolid, , Spain
Sylentis Investigative Site
Zaragoza, , Spain
Countries
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Other Identifiers
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SYL1001_V
Identifier Type: -
Identifier Source: org_study_id
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