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

June 16, 2026 updated by: Huons Co., Ltd.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Phase 2 Clinical Study to Evaluate the Efficacy and Safety of HUC1-394 in Participant With Dry Eye Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 informed consent after receiving a full explanation and understanding of the clinical trial

Exclusion Criteria:

  • Trial participants with clinically significant 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 autoimmune diseases or immunodeficiency disorders
  • Pregnant or lactating women, or women of childbearing potential and men of reproductive potential who plan to conceive during the clinical trial or are unwilling to use an appropriate method of contraception
  • Trial participants who have participated in another clinical trial and received an investigational 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
ophthalmic solution. Participants will instill 1 drop in each eye
Experimental: HUC1-394 BID
Drug: HUC1-394
ophthalmic solution. Participants will instill 1 drop in each eye
Experimental: HUC1-394 TID
Drug: HUC1-394
ophthalmic solution. Participants will instill 1 drop in each eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Total Corneal Staining Score (TCSS)
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huons Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUC1-394-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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