Safety Study of Tivanisiran to Treat Dry Eye

• Status: Recruiting
• Trial end date: 2023-10-24
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sylentis, S.A.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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