Clinical trial NCT05310422: Safety Study of Tivanisiran to Treat Dry Eye
Official title: Safety Study of Tivanisiran to Treat Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: siRNA
oligonucleotide
keratoconjunctivitis sicca
SYL1001
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Sylentis Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Sylentis Investigative Site
state: Arizona
city: Glendale
country: United States
facility: FYDES Investigative Site
state: California
city: Hemet
country: United States
facility: Sylentis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Sylentis Investigative Site
state: California
city: Murrieta
country: United States
facility: Sylentis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Sylentis Investigative Site
state: California
city: Delray Beach
country: United States
facility: FYDES Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: FYDES Investigative Site
state: Florida
city: Largo
country: United States
facility: Sylentis Investigative Site
state: Florida
city: Morrow
country: United States
facility: Sylentis Investigative Site
state: Georgia
city: Fraser
country: United States
facility: Sylentis Investigative Site
state: Michigan
city: Kansas City
country: United States
facility: Sylentis Investigative Site
state: Missouri
city: Saint Louis
country: United States
facility: FYDES Investigative Site
state: Missouri
city: Washington
country: United States
facility: Sylentis Investigative Site
state: Missouri
city: Rochester
country: United States
facility: Sylentis Investigative Site
state: New York
city: Asheville
country: United States
facility: Sylentis Investigative Site
state: North Carolina
city: Garner
country: United States
facility: Sylentis Investigative Site
state: North Carolina
city: Cranberry Township
country: United States
facility: Sylentis Investigative Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Sylentis Investigative Site
state: South Dakota
city: Memphis
country: United States
facility: Sylentis Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Sylentis Investigative Site
state: Texas
city: El Paso
country: United States
facility: FYDES Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Sylentis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Sylentis Investigative Site
state: Texas
Study officials:
References: