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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 up to 5 years
Awards & highlights
Summary
This trial is testing the safety of tivanisiran sodium eye drops in people with dry eye disease. The goal is to see if these eye drops can be safely used over time to help reduce inflammation and improve tear production.
Eligible Conditions
- Dry Eye Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that the investigator believes could affect your participation in the study.You have not used artificial tears, autologous serum, or certain dry eye medications within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Tivanisiran sodium ophthalmic solution
- Group 2: Vehicle ophthalmic solution
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05310422 — Phase 3
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