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RNA Interference

Tivanisiran sodium ophthalmic solution for Dry Eye Syndrome (FYDES Trial)

Phase 3
Waitlist Available
Research Sponsored by Sylentis, S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

FYDES Trial Summary

This trial will compare the safety of tivanisiran sodium eye drops to a placebo in people with dry eye disease, dosed once daily for a year.

Eligible Conditions
  • Dry Eye Syndrome

FYDES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year

FYDES Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tivanisiran sodium ophthalmic solutionExperimental Treatment1 Intervention
Group II: Vehicle ophthalmic solutionPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tivanisiran sodium ophthalmic solution
2022
Completed Phase 3
~510

Find a Location

Who is running the clinical trial?

Sylentis, S.A.Lead Sponsor
11 Previous Clinical Trials
1,139 Total Patients Enrolled

Media Library

Tivanisiran sodium ophthalmic solution (RNA Interference) Clinical Trial Eligibility Overview. Trial Name: NCT05310422 — Phase 3
Dry Eye Syndrome Research Study Groups: Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution
Dry Eye Syndrome Clinical Trial 2023: Tivanisiran sodium ophthalmic solution Highlights & Side Effects. Trial Name: NCT05310422 — Phase 3
Tivanisiran sodium ophthalmic solution (RNA Interference) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05310422 — Phase 3
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05310422 — Phase 3
~95 spots leftby Jun 2025