Clinical trial NCT04819269: Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Official title: Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Sjögren Syndrome
Keywords: oligonucleotide
siRNA
keratoconjunctivitis sicca
SYL1001
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 203
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 efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome.


Eligibility criteria: Inclusion Criteria:

* Subject is a male or a female aged ≥ 18 years
* 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
* Willing to not use AT or autologous serum for the study duration
* VAS scale for Dry Eye Symptom Score ≥ 40
* Total CFS ≥ 5
* Schirmer's test with anesthesia \< 10 mm/5min
* Patients with Sjögren Syndrome

Exclusion Criteria:

* Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
* Use of contact lenses during the study
* Significant Eye diseases according to investigator's opinion

Primary outcomes:
measure: Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
timeFrame: 85 days
measure: Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
timeFrame: 85 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sylentis Investigative Site
state: Alabama
city: Dothan
country: United States
facility: Sylentis Investigative Site
state: Alabama
city: Scottsdale
country: United States
facility: Sylentis Investigative Site
state: Arizona
city: Garden Grove
country: United States
facility: Sylentis Investigative Site
state: California
city: Glendale
country: United States
facility: Sylentis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Sylentis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Sylentis Investigative Site
state: California
city: Rancho Cordova
country: United States
facility: Sylentis Investigative Site
state: California
city: San Diego
country: United States
facility: Sylentis Investigative Site
state: California
city: Torrance
country: United States
facility: Sylentis Investigative Site
state: California
city: Aurora
country: United States
facility: Sylentis Investigative Site
state: Colorado
city: Colorado Springs
country: United States
facility: Sylentis Investigative Site
state: Colorado
city: Littleton
country: United States
facility: Sylentis Investigative Site
state: Colorado
city: Jacksonville
country: United States
facility: Sylentis Investigative Site
state: Florida
city: Largo
country: United States
facility: Sylentis Investigative Site
state: Florida
city: Miami
country: United States
facility: Sylentis Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Sylentis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Sylentis Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Sylentis Investigative Site
state: Georgia
city: Morrow
country: United States
facility: Sylentis Investigative Site
state: Georgia
city: Carmel
country: United States
facility: Sylentis Investigative Site
state: Indiana
city: Waltham
country: United States
facility: Sylentis Investigative Site
state: Massachusetts
city: Ypsilanti
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: Sylentis Investigative Site
state: Missouri
city: Washington
country: United States
facility: Sylentis Investigative Site
state: Missouri
city: Asheville
country: United States
facility: Sylentis Investigative Site
state: North Carolina
city: High Point
country: United States
facility: Sylentis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Sylentis Investigative Site
state: North Dakota
city: Cleveland
country: United States
facility: Sylentis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Sylentis Investigative Site
state: Ohio
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: Nashville
country: United States
facility: Sylentis Investigative Site
state: Tennessee
city: El Paso
country: United States
facility: Sylentis Investigative Site
state: Texas
city: Houston
country: United States
facility: Sylentis Investigative Site
state: Texas
city: Houston
country: United States
facility: Sylentis Investigative Site
state: Texas
city: Falls Church
country: United States
facility: Sylentis Investigative Site
state: Virginia
city: Pamplona
country: Spain
facility: Sylentis Investigative Site
state: Navarra
city: Barcelona
country: Spain
facility: Sylentis Investigative Site
city: Madrid
country: Spain
facility: Sylentis Investigative Site
city: Madrid
country: Spain
facility: Sylentis Investigative Site
city: Sevilla
country: Spain
facility: Sylentis Investigative Site
city: Valladolid
country: Spain
facility: Sylentis Investigative Sites
city: Zaragoza
country: Spain
facility: Sylentis Investigative Site
Study officials:
References: