ClinicalTrials.gg
RecruitingNCT07656688Updated Jul 1, 2026

Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease

A Phase 2 interventional study of HUC1-394 and Placebo in Dry Eye Disease (DED), sponsored by Huons Co., Ltd.. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Huons Co., Ltd. (part of Huons Global) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Clinical trial aims to determine the optimal dosing regimen by evaluating the efficacy and safety of HUC1-394 across different dosing frequencies in patients with moderate to severe dry eye disease.

02

Conditions studied

  • Dry Eye Disease (DED)

Browse trials for

03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 150 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Huons Co., Ltd. is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged ≥ 19 years at the time of screening
  • Trial participants who have experienced at least one of the following dry eye disease symptoms for at least 3 months prior to the time of screening
  • Trial participants who meet all of the following criteria in at least one eye (left or right) at the time of screening and randomization:

TCSS (NEI grading) ≥ 4 / Non-anesthetic Schirmer test result > 0 mm and ≤ 10 mm/5 min / TBUT \< 7 seconds

  • OSDI score ≥ 23 at the time of screening
  • Trial participants who have provided voluntary written after receiving a full explanation and understanding of the clinical trial

Exclusion criteria

Exclusion Criteria:

  • Trial participants with ophthalmic diseases that may confound the interpretation of clinical trial results
  • Trial participants with blepharospasm, entropion, ectropion, or abnormalities of the eyelashes
  • Trial participants with any active ophthalmic disease that may affect the ocular surface, such as active allergy, anterior uveitis, and Stevens-Johnson syndrome
  • Trial participants with a history of corneal transplantation or neurotrophic keratitis
  • Trial participants with diseases or immunodeficiency disorders
  • Pregnant or lactating women, or women of and men of who plan to conceive during the clinical trial or are unwilling to use an appropriate method of
  • Trial participants who have participated in another clinical trial and received an product or used an investigational medical device within 30 days prior to the time of screening
  • Trial participants who are deemed ineligible for participation by the investigator for any other reason in the clinical trial
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    HUC1-394 BID

    Drug: HUC1-394

  • Experimental
    HUC1-394 TID

    Drug: HUC1-394

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHUC1-394

    ophthalmic solution. Participants will instill 1 drop in each eye

  • DrugPlacebo

    ophthalmic solution. Participants will instill 1 drop in each eye

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Total Corneal Staining Score (TCSS) Using the National Eye Institute (NEI) Scale

    NEI scale (range 0-15; higher scores indicate a worse outcome)

    Time frame: Week 12

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2026; primary completion for Jun 2027, 11 months later.

Of 75 industry-sponsored phase 2 interventional studies under Dry Eye Syndromes, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 11. This study's planned 11 months is above that.

Counting every sponsor, half of 91 studies reached it within 7 months; a quarter within 5 and three quarters within 12.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 16, 2026
First posted
Jun 18, 2026
StartEst.
Jul 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07656688
Lead sponsor
Huons Co., Ltd.
Responsible party
Sponsor
First posted
Jun 18, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jul 1, 2026

Study contacts

study manager
Contact
rlee@huons.com
07074926091

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion