Safety Study of Tivanisiran to Treat Dry Eye
Phase 3
Completed
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Tivanisiran sodium ophthalmic solutionDrug: Vehicle ophthalmic solution
- Registration Number
- NCT05310422
- Lead Sponsor
- Sylentis, S.A.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tivanisiran sodium ophthalmic solution Tivanisiran sodium ophthalmic solution - Vehicle ophthalmic solution Vehicle ophthalmic solution -
- Primary Outcome Measures
Name Time Method Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
FYDES Investigative Site
🇺🇸El Paso, Texas, United States
Sylentis Investigative Site
🇺🇸San Antonio, Texas, United States