Dry Eye Disease Clinical Trial
— FYDESOfficial title:
Safety Study of Tivanisiran to Treat Dry Eye
| 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 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).
| Status | Completed |
| Enrollment | 301 |
| Est. completion date | October 11, 2023 |
| Est. primary completion date | October 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Sylentis Investigative Site | Asheville | North Carolina |
| United States | Sylentis Investigative Site | Austin | Texas |
| United States | Sylentis Investigative Site | Chandler | Arizona |
| United States | Sylentis Investigative Site | Cranberry Township | Pennsylvania |
| United States | FYDES Investigative Site | Delray Beach | Florida |
| United States | FYDES Investigative Site | El Paso | Texas |
| United States | Sylentis Investigative Site | Fraser | Michigan |
| United States | Sylentis Investigative Site | Garner | North Carolina |
| United States | FYDES Investigative Site | Glendale | California |
| United States | Sylentis Investigative Site | Hemet | California |
| United States | FYDES Investigative Site | Jacksonville | Florida |
| United States | Sylentis Investigative Site | Kansas City | Missouri |
| United States | Sylentis Investigative Site | Largo | Florida |
| United States | Sylentis Investigative Site | Los Angeles | California |
| United States | Sylentis Investigative Site | Memphis | Tennessee |
| United States | Sylentis Investigative Site | Morrow | Georgia |
| United States | Sylentis Investigative Site | Murrieta | California |
| United States | Sylentis Investigative Site | Newport Beach | California |
| United States | Sylentis Investigative Site | Phoenix | Arizona |
| United States | Sylentis Investigative Site | Rapid City | South Dakota |
| United States | Sylentis Investigative Site | Rochester | New York |
| United States | FYDES Investigative Site | Saint Louis | Missouri |
| United States | Sylentis Investigative Site | San Antonio | Texas |
| United States | Sylentis Investigative Site | San Antonio | Texas |
| United States | Sylentis Investigative Site | Washington | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Sylentis, S.A. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year | 1 year |
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