Dry Eye Disease Clinical Trial
Official title:
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
| Verified date | February 2024 |
| Source | Sylentis, S.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 203 |
| Est. completion date | December 11, 2023 |
| Est. primary completion date | December 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Sylentis Investigative Site | Barcelona | |
| Spain | Sylentis Investigative Site | Madrid | |
| Spain | Sylentis Investigative Site | Madrid | |
| Spain | Sylentis Investigative Site | Pamplona | Navarra |
| Spain | Sylentis Investigative Site | Sevilla | |
| Spain | Sylentis Investigative Sites | Valladolid | |
| Spain | Sylentis Investigative Site | Zaragoza | |
| United States | Sylentis Investigative Site | Asheville | North Carolina |
| United States | Sylentis Investigative Site | Atlanta | Georgia |
| United States | Sylentis Investigative Site | Aurora | Colorado |
| United States | Sylentis Investigative Site | Birmingham | Alabama |
| United States | Sylentis Investigative Site | Carmel | Indiana |
| United States | Sylentis Investigative Site | Cleveland | Ohio |
| United States | Sylentis Investigative Site | Colorado Springs | Colorado |
| United States | Sylentis Investigative Site | Columbus | Ohio |
| United States | Sylentis Investigative Site | Cranberry Township | Pennsylvania |
| United States | Sylentis Investigative Site | Dothan | Alabama |
| United States | Sylentis Investigative Site | El Paso | Texas |
| United States | Sylentis Investigative Site | Falls Church | Virginia |
| United States | Sylentis Investigative Site | Fargo | North Dakota |
| United States | Sylentis Investigative Site | Garden Grove | California |
| United States | Sylentis Investigative Site | Glendale | California |
| United States | Sylentis Investigative Site | High Point | North Carolina |
| United States | Sylentis Investigative Site | Houston | Texas |
| United States | Sylentis Investigative Site | Houston | Texas |
| United States | Sylentis Investigative Site | Jacksonville | Florida |
| United States | Sylentis Investigative Site | Kansas City | Missouri |
| United States | Sylentis Investigative Site | Largo | Florida |
| United States | Sylentis Investigative Site | Littleton | Colorado |
| United States | Sylentis Investigative Site | Los Angeles | California |
| United States | Sylentis Investigative Site | Memphis | Tennessee |
| United States | Sylentis Investigative Site | Miami | Florida |
| United States | Sylentis Investigative Site | Morrow | Georgia |
| United States | Sylentis Investigative Site | Nashville | Tennessee |
| United States | Sylentis Investigative Site | Newport Beach | California |
| United States | Sylentis Investigative Site | Ormond Beach | Florida |
| United States | Sylentis Investigative Site | Rancho Cordova | California |
| United States | Sylentis Investigative Site | Rapid City | South Dakota |
| United States | Sylentis Investigative Site | Saint Louis | Missouri |
| United States | Sylentis Investigative Site | San Diego | California |
| United States | Sylentis Investigative Site | Scottsdale | Arizona |
| United States | Sylentis Investigative Site | Tampa | Florida |
| United States | Sylentis Investigative Site | Torrance | California |
| United States | Sylentis Investigative Site | Waltham | Massachusetts |
| United States | Sylentis Investigative Site | Washington | Missouri |
| United States | Sylentis Investigative Site | Ypsilanti | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Sylentis, S.A. |
United States, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. | 85 days | ||
| Primary | Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. | 85 days |
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