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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
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
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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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