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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
203
1 drop in the affected eye(s) once daily
1 drop in the affected eye(s) once daily
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
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