Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

• Status: Recruiting
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

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