Safety Study of Tivanisiran to Treat Dry Eye

Completed · Phase 3

Conditions studied: Dry Eye Disease

In brief

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).

Key facts

Study ID

NCT05310422

Run by

Sylentis, S.A.

People needed

301

Starts

2022-03-24

Expected to finish

2023-10-11

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sylentis Investigative Site — Chandler, Arizona, United States
• Sylentis Investigative Site — Phoenix, Arizona, United States
• FYDES Investigative Site — Glendale, California, United States
• Sylentis Investigative Site — Hemet, California, United States
• Sylentis Investigative Site — Los Angeles, California, United States
• Sylentis Investigative Site — Murrieta, California, United States
• Sylentis Investigative Site — Newport Beach, California, United States
• FYDES Investigative Site — Delray Beach, Florida, United States
• FYDES Investigative Site — Jacksonville, Florida, United States
• Sylentis Investigative Site — Largo, Florida, United States
• Sylentis Investigative Site — Morrow, Georgia, United States
• Sylentis Investigative Site — Fraser, Michigan, United States
• Sylentis Investigative Site — Kansas City, Missouri, United States
• FYDES Investigative Site — St Louis, Missouri, United States
• Sylentis Investigative Site — Washington, Missouri, United States
• Sylentis Investigative Site — Rochester, New York, United States
• Sylentis Investigative Site — Asheville, North Carolina, United States
• Sylentis Investigative Site — Garner, North Carolina, 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 — Austin, Texas, United States
• FYDES Investigative Site — El Paso, Texas, United States
• Sylentis Investigative Site — San Antonio, Texas, United States
• Sylentis Investigative Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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