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New eye drops take on dry eye in Head-to-Head trial

NCT ID NCT06388070

Symptom relief Sponsor: Huons Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a new eye drop called HUC3-053 works as well as an existing drop (Hyalein) for dry eye. 297 adults used the drops 5-6 times daily for 12 weeks. The study measured changes in eye surface staining and other signs of dry eye.

What this could mean

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

Active substance
HUC3-053 eye drops (0.3% hyaluronic acid)
What this could lead to
If it works, this could offer a new option for relieving dry eye symptoms, similar to existing hyaluronic acid drops.
What could go wrong
This is a non-inferiority trial, meaning it aims to show HUC3-053 is as good as, not better than, an existing treatment. Even if successful, it may not offer additional benefits.

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

297 people

The number who actually took part.

Started

May 2024

Finished

Mar 2025

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

19 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: * Age over 19 * Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit. * Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes * Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit Exclusion Criteria: * The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c\>9% * Wearing contact lenses within 72 hr of screening visit * Pregnancy or Breastfeeding

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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 syndromes

Contacts and locations

Locations

  • Gangbuk Samsung Hospital

    Seoul, Jongno-gu, 03181, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.