This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).

Inclusion Criteria:

• Be at least 18 years of age
• 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

Exclusion Criteria:

• Pregnant or breast feeding females with a postitive pregnancy test
• Women of childbearing potential not willing to use a medically acceptable contraceptive method
• Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
• Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
• Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial