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Safety Study of Tivanisiran to Treat Dry Eye

NCT05310422 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2024-02-20

No results posted yet for this study

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).

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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-10-11
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States

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 NCT05310422 on ClinicalTrials.gov