Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Primary Purpose
Dry Eye Disease, Sjögren Syndrome
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tivanisiran sodium ophthalmic solution
Vehicle ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease focused on measuring oligonucleotide, siRNA, keratoconjunctivitis sicca, SYL1001
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
Sites / Locations
- Sylentis Investigative SiteRecruiting
- Sylentis Investigative SiteRecruiting
- Sylentis Investigative Site
- Sylentis Investigative SiteRecruiting
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- Sylentis Investigative Site
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- Sylentis Investigative Site
- Sylentis Investigative SiteRecruiting
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- Sylentis Investigative Site
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- Sylentis Investigative SiteRecruiting
- Sylentis Investigative Site
- Sylentis Investigative SiteRecruiting
- Sylentis Investigative SiteRecruiting
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tivanisiran sodium ophthalmic solution
Vehicle ophthalmic solution
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04819269
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease, Sjögren Syndrome
Keywords
oligonucleotide, siRNA, keratoconjunctivitis sicca, SYL1001
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tivanisiran sodium ophthalmic solution
Arm Type
Active Comparator
Arm Title
Vehicle ophthalmic solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tivanisiran sodium ophthalmic solution
Intervention Description
1 drop in the affected eye(s) once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle ophthalmic solution
Intervention Description
1 drop in the affected eye(s) once daily
Primary Outcome Measure Information:
Title
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
Time Frame
85 days
Title
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
Time Frame
85 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sylentis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Terminated
Facility Name
Sylentis Investigative Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Individual Site Status
Terminated
Facility Name
Sylentis Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Terminated
Facility Name
Sylentis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Individual Site Status
Terminated
Facility Name
Sylentis Investigative Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
egulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Terminated
Facility Name
Sylentis Investigative Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Terminated
Facility Name
Sylentis Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Sites
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
Facility Name
Sylentis Investigative Site
City
Zaragoza
ZIP/Postal Code
50004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regulatory Affairs Department
Email
info@sylentis.com
12. IPD Sharing Statement
Learn more about this trial
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
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