Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Phase 3
Completed
- Conditions
- Dry Eye DiseaseSjögren Syndrome
- Interventions
- Drug: Vehicle ophthalmic solutionDrug: Tivanisiran sodium ophthalmic solution
- Registration Number
- NCT04819269
- Lead Sponsor
- Sylentis, S.A.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle ophthalmic solution Vehicle ophthalmic solution - Tivanisiran sodium ophthalmic solution Tivanisiran sodium ophthalmic solution -
- Primary Outcome Measures
Name Time Method Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. 85 days Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. 85 days
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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What are the potential adverse events of Tivanisiran sodium eye drops in NCT04819269 for Sjögren's Syndrome patients?
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Trial Locations
- Locations (2)
Sylentis Investigative Site
🇪🇸Zaragoza, Spain
Sylentis Investigative Sites
🇪🇸Valladolid, Spain
Sylentis Investigative Site🇪🇸Zaragoza, Spain