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Can a daily eye drop safely treat dry eye? phase 3 trial puts tivanisiran to the test

NCT ID NCT05310422

Symptom relief Sponsor: Sylentis, S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing tivanisiran sodium eye drops in adults with dry eye disease to see if the drops are safe when used once daily for a year. About 300 participants will receive either the tivanisiran drops or a vehicle drop, which is a solution without the active ingredient. The study tracks eye and non-eye side effects over the full year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tivanisiran sodium ophthalmic solution
What this could lead to
If it works, this could offer a new daily eye drop option for people whose dry eye symptoms persist despite artificial tears.
What could go wrong
This study focuses on safety, not proof that the drops relieve symptoms. Eye drops can cause irritation, and a year of daily use may reveal side effects that shorter studies miss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

301 people

The number who actually took part.

Started

Mar 2022

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be at least 18 years of age * Have given their written consent to participate in the study * Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection Exclusion Criteria: * Pregnant or breast feeding females with a positive pregnancy test * Women of childbearing potential not willing to use a medically acceptable contraceptive method * Currently participating or has participated in another clinical trial within the 2 months prior to inclusion * Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study * Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye disease

Contacts and locations

Locations

  • FYDES Investigative Site

    Glendale, California, 91204, United States

  • FYDES Investigative Site

    Delray Beach, Florida, 33484, United States

  • FYDES Investigative Site

    Jacksonville, Florida, 32256, United States

  • FYDES Investigative Site

    St Louis, Missouri, 63131, United States

  • FYDES Investigative Site

    El Paso, Texas, 79902, United States

  • Sylentis Investigative Site

    Chandler, Arizona, 85021, United States

  • Sylentis Investigative Site

    Phoenix, Arizona, 85032, United States

  • Sylentis Investigative Site

    Hemet, California, 92545, United States

  • Sylentis Investigative Site

    Los Angeles, California, 85032, United States

  • Sylentis Investigative Site

    Murrieta, California, 92562, United States

  • Sylentis Investigative Site

    Newport Beach, California, 92663, United States

  • Sylentis Investigative Site

    Largo, Florida, 33773, United States

  • Sylentis Investigative Site

    Morrow, Georgia, 30260, United States

  • Sylentis Investigative Site

    Fraser, Michigan, 48026, United States

  • Sylentis Investigative Site

    Kansas City, Missouri, 64111, United States

  • Sylentis Investigative Site

    Washington, Missouri, 63090, United States

  • Sylentis Investigative Site

    Rochester, New York, 14618, United States

  • Sylentis Investigative Site

    Asheville, North Carolina, 28803, United States

  • Sylentis Investigative Site

    Garner, North Carolina, 27529, United States

  • Sylentis Investigative Site

    Cranberry Township, Pennsylvania, 16066, United States

  • Sylentis Investigative Site

    Rapid City, South Dakota, 57701, United States

  • Sylentis Investigative Site

    Memphis, Tennessee, 38119, United States

  • Sylentis Investigative Site

    Austin, Texas, 78731, United States

  • Sylentis Investigative Site

    San Antonio, Texas, 78215, United States

  • Sylentis Investigative Site

    San Antonio, Texas, 78230, United States

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