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Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

NCT04819269 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tivanisiran sodium ophthalmic solution

1 drop in the affected eye(s) once daily

DRUG

Vehicle ophthalmic solution

1 drop in the affected eye(s) once daily

Sponsors & Collaborators

  • Sylentis, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2023-12-11
Completion
2023-12-11
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819269 on ClinicalTrials.gov