Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Phase 3

Completed

• Conditions: Dry Eye Disease; Sjögren Syndrome
• Interventions: Drug: Vehicle ophthalmic solution; Drug: Tivanisiran sodium ophthalmic solution

• Registration Number: NCT04819269
• Lead Sponsor: Sylentis, S.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Study Start: 2021-05-25
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle ophthalmic solution	Vehicle ophthalmic solution	-
Tivanisiran sodium ophthalmic solution	Tivanisiran sodium ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.	85 days
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.	85 days

Trial Locations

Locations (2)

Sylentis Investigative Site; 🇪🇸 Zaragoza, Spain

Sylentis Investigative Sites; 🇪🇸 Valladolid, Spain