Safety Study of Tivanisiran to Treat Dry Eye
FYDES
1 other identifier
interventional
301
1 country
25
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2022
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2022
CompletedFirst Submitted
Initial submission to the registry
March 25, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2023
CompletedFebruary 20, 2024
February 1, 2024
1.6 years
March 25, 2022
February 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year
1 year
Study Arms (2)
Tivanisiran sodium ophthalmic solution
EXPERIMENTALVehicle ophthalmic solution
PLACEBO COMPARATORInterventions
1 drop in the affected eye(s) once daily
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sylentis, S.A.lead
Study Sites (25)
Sylentis Investigative Site
Chandler, Arizona, 85021, United States
Sylentis Investigative Site
Phoenix, Arizona, 85032, United States
FYDES Investigative Site
Glendale, California, 91204, United States
Sylentis Investigative Site
Hemet, California, 92545, United States
Sylentis Investigative Site
Los Angeles, California, 85032, United States
Sylentis Investigative Site
Murrieta, California, 92562, United States
Sylentis Investigative Site
Newport Beach, California, 92663, United States
FYDES Investigative Site
Delray Beach, Florida, 33484, United States
FYDES Investigative Site
Jacksonville, Florida, 32256, United States
Sylentis Investigative Site
Largo, Florida, 33773, United States
Sylentis Investigative Site
Morrow, Georgia, 30260, United States
Sylentis Investigative Site
Fraser, Michigan, 48026, United States
Sylentis Investigative Site
Kansas City, Missouri, 64111, United States
FYDES Investigative Site
St Louis, Missouri, 63131, United States
Sylentis Investigative Site
Washington, Missouri, 63090, United States
Sylentis Investigative Site
Rochester, New York, 14618, United States
Sylentis Investigative Site
Asheville, North Carolina, 28803, United States
Sylentis Investigative Site
Garner, North Carolina, 27529, United States
Sylentis Investigative Site
Cranberry Township, Pennsylvania, 16066, United States
Sylentis Investigative Site
Rapid City, South Dakota, 57701, United States
Sylentis Investigative Site
Memphis, Tennessee, 38119, United States
Sylentis Investigative Site
Austin, Texas, 78731, United States
FYDES Investigative Site
El Paso, Texas, 79902, United States
Sylentis Investigative Site
San Antonio, Texas, 78215, United States
Sylentis Investigative Site
San Antonio, Texas, 78230, United States
Related Publications (1)
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PMID: 36729473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2022
First Posted
April 5, 2022
Study Start
March 24, 2022
Primary Completion
October 11, 2023
Study Completion
October 11, 2023
Last Updated
February 20, 2024
Record last verified: 2024-02