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

NCT07656688 | Recruiting Phase 2 DMC

• 1 other identifier: HUC1-394-201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

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)

  Week 12

Study Arms (3)

HUC1-394 BID

EXPERIMENTAL

Drug: HUC1-394

HUC1-394 TID

EXPERIMENTAL

Drug: HUC1-394

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HUC1-394 DRUG

ophthalmic solution. Participants will instill 1 drop in each eye

HUC1-394 BID; HUC1-394 TID

Placebo DRUG

ophthalmic solution. Participants will instill 1 drop in each eye

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

study manager

CONTACT

07074926091; rlee@huons.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)