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Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT04819269
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.

Tracking Information
First Submitted Date  ICMJE March 24, 2021
First Posted Date  ICMJE March 26, 2021
Last Update Posted Date September 8, 2021
Actual Study Start Date  ICMJE May 25, 2021
Estimated Primary Completion Date April 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
  • Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. [ Time Frame: 85 days ]
  • Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. [ Time Frame: 85 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Change from baseline in total Corneal Fluorescein Staining (CFS) score [ Time Frame: 85 days ]
  • Change from baseline in Dry Eye Symptom score [ Time Frame: 85 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Official Title  ICMJE Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye Disease
  • Sjögren Syndrome
Intervention  ICMJE
  • Drug: Tivanisiran sodium ophthalmic solution
    1 drop in the affected eye(s) once daily
  • Drug: Vehicle ophthalmic solution
    1 drop in the affected eye(s) once daily
Study Arms  ICMJE
  • Active Comparator: Tivanisiran sodium ophthalmic solution
    Intervention: Drug: Tivanisiran sodium ophthalmic solution
  • Placebo Comparator: Vehicle ophthalmic solution
    Intervention: Drug: Vehicle ophthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 20, 2022
Estimated Primary Completion Date April 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04819269
Other Study ID Numbers  ICMJE SYL1001_V
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sylentis, S.A.
Study Sponsor  ICMJE Sylentis, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sylentis, S.A.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP