Status:
COMPLETED
Safety Study of Tivanisiran to Treat Dry Eye
Lead Sponsor:
Sylentis, S.A.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2023
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT05310422
Start Date
March 24 2022
End Date
October 11 2023
Last Update
February 20 2024
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Sylentis Investigative Site
Chandler, Arizona, United States, 85021
2
Sylentis Investigative Site
Phoenix, Arizona, United States, 85032
3
FYDES Investigative Site
Glendale, California, United States, 91204
4
Sylentis Investigative Site
Hemet, California, United States, 92545