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RNA Interference

Tivanisiran for Dry Eye in Sjögren's Syndrome

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
Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection
Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of tivanisiran sodium eye drops to artificial tears (vehicle) in people with dry eye disease caused by Sjögren's Syndrome, after a 2-week run-in phase.

Who is the study for?
This trial is for adults with Sjögren's Syndrome who suffer from dry eye disease. Participants must have a certain level of dry eye symptoms and not use artificial tears or other specific medications during the study. They can't join if they've had recent eye procedures, surgeries, significant eye diseases, or changes in systemic medication doses.Check my eligibility
What is being tested?
The study tests tivanisiran sodium ophthalmic solution against a placebo (vehicle ophthalmic solution) to see if it's effective and safe when used daily for three months by people with dry eyes due to Sjögren's Syndrome.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions associated with ophthalmic solutions such as irritation, redness, discomfort, or allergic reactions at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used artificial tears or specific dry eye treatments in the last 6 months.
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I have used artificial tears or specific dry eye treatments in the last 6 months.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Tivanisiran sodium ophthalmic solutionActive Control1 Intervention
Group II: Vehicle ophthalmic solutionPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Sylentis, S.A.Lead Sponsor
11 Previous Clinical Trials
1,237 Total Patients Enrolled

Media Library

Tivanisiran sodium ophthalmic solution (RNA Interference) Clinical Trial Eligibility Overview. Trial Name: NCT04819269 — Phase 3
Dry Eye Syndrome Research Study Groups: Vehicle ophthalmic solution, Tivanisiran sodium ophthalmic solution
Dry Eye Syndrome Clinical Trial 2023: Tivanisiran sodium ophthalmic solution Highlights & Side Effects. Trial Name: NCT04819269 — Phase 3
Tivanisiran sodium ophthalmic solution (RNA Interference) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04819269 — Phase 3
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT04819269 — Phase 3

Frequently Asked Questions

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

Are there any participating hospitals in Canada?

"There are a total of 34 sites running this study at the moment, with centres in locations such as Birmingham, Largo and Saint Louis. If you are considering participating, be sure to choose a location near you to limit travel."

Answered by AI

Has Tivanisiran's ophthalmic solution received FDA approval?

"Tivanisiran sodium ophthalmic solution is considered safe based on Phase 3 trial data. This means that the medication has shown some efficacy in prior trials and has undergone multiple rounds of testing to support its safety."

Answered by AI

Is there still room for more people in this trial?

"The clinical trial is still open and actively recruiting patients, as of 9/15/2022. This can be seen on clinicaltrials.gov, where the study was first posted on 5/25/2021. In total, the clinical trial needs 200 participants, which 34 different locations across the country."

Answered by AI

How many volunteers are currently enrolling in this research project?

"That is correct. The information displayed on clinicaltrials.gov reveals that this study is still recruiting patients. This specific trial was first posted on May 25th, 2021 and was edited most recently on September 15th, 2022. In total, the study needs 200 participants from 34 different locations."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Texas
Other
California
How old are they?
65+
What site did they apply to?
Sylentis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

Rheumatoid arthritis treatment. I have struggled with dry eyes for years. Because I need my eyes and want to have good vision.
PatientReceived 1 prior treatment
Had some odd eye events since May. Hope to find answers soon. Frustration with dry eye symptoms in spite of use of lubricant drops.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What does trial entail? Duration of trial? Any restrictions beside non use of AT?
PatientReceived 2+ prior treatments
~53 spots leftby Apr 2025