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New eye drop shows promise for dry eye sufferers in Late-Stage trial

NCT ID NCT05411367

Symptom relief Sponsor: Seikagaku Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested SI-614 eye drops, a modified form of sodium hyaluronate, against placebo in 232 adults with dry eye disease. Participants used the drops four times daily for 84 days. The study measured changes in eye surface staining (a sign of damage) and daily symptom scores. The goal is to see if SI-614 can safely reduce eye discomfort and improve eye surface health better than placebo.

What this could mean

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

Active substance
SI-614 (a chemically modified form of sodium hyaluronate) eye drops
What this could lead to
If successful, SI-614 could offer a new treatment option to reduce eye surface damage and ease discomfort in people with dry eye disease.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The improvement over placebo may be small, and not everyone may benefit. Dry eye is complex and symptoms vary widely.

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

232 people

The number who actually took part.

Started

Jul 2022

Finished

Apr 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: * Have history of dry eye in both eyes for at least 6 months prior to Visit 1. * Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1. * If a female of childbearing potential, have a negative urine pregnancy test at Visit 1 and will be using an adequate method of birth control throughout the study period. Exclusion Criteria: * Have any clinically significant slit lamp findings at Visit 1 or Visit 2, including active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular allergies that requires therapeutic treatment and/or, in the opinion of the investigator, may interfere with the study parameters. * Be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (eg, follicular conjunctivitis) at Visit 1 or Visit 2. * Have had any ocular surgical procedure within 12 months prior to Visit 1, or have any scheduled ocular surgical procedure during the study period. * Be a female who is pregnant, nursing an infant, or planning a pregnancy. * Have a known allergy and/or sensitivity to the study drug or its components. * Have a condition or is in a situation that, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patients' participation in the study.

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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

  • Andover Eye Associates, Inc.

    Andover, Massachusetts, 01810, United States

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • CORE Inc, Vita Eye Clinic

    Shelby, North Carolina, 28150, United States

  • Center for Sight

    Henderson, Nevada, 89052, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • Total Eye Care, PA

    Memphis, Tennessee, 38119, United States

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