Dry Eye Disease (DED)Phase 2NCT07656688
Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease
A Phase 2 study testing HUC1-394 in people with Dry Eye Disease (DED), run by Huons Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- HUC1-394
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2026to Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: 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.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- HUC1-394, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUC1-394Drug
ophthalmic solution. Participants will instill 1 drop in each eye
PlaceboDrug
ophthalmic solution. Participants will instill 1 drop in each eye
| Study group | Role | What they receive |
|---|---|---|
| HUC1-394 BID | Experimental | Not described Receives: Drug: HUC1-394 |
| HUC1-394 TID | Experimental | Not described Receives: Drug: HUC1-394 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656688
- Sponsor's protocol ID
- HUC1-394-201
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No