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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Where are patients able to participate in this trial?

"There are 24 sites currently running this clinical trial, which are based in Washington, Largo and Asheville as well as 21 other locations. If you enroll in the trial, it would be most convenient to select the site nearest to your location to minimize travel requirements."

Answered by AI

Are people still able to sign-up for this experiment?

"According to the listing on clinicaltrials.gov, this particular trial is not currently seeking patients for participation. This study was originally posted on March 24th, 2022 but has since stopped recruiting candidates. However, there are still many other trials (144 in total) that are open for enrollment."

Answered by AI

When did Tivanisiran sodium ophthalmic solution receive FDA clearance?

"Tivanisiran sodium ophthalmic solution is in Phase 3 trials, meaning that while there is some data supporting efficacy, multiple rounds of data are needed to support safety."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Arizona
What site did they apply to?
Sylentis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am tired of having dry eyes. I use muro 128 every night for my dry eyes.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Safety Study of Tivanisiran to Treat Dry Eye
2022. "Safety Study of Tivanisiran to Treat Dry Eye". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05310422.
~98 spots leftby Apr 2025
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