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.

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