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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07656688
- Acronym / sponsor ID
- HUC1-394-201
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HUC1-394 BID | Experimental | Drug: HUC1-394 |
| HUC1-394 TID | Experimental | Drug: HUC1-394 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUC1-394ophthalmic solution. Participants will instill 1 drop in each eye | Drug | HUC1-394 BID, HUC1-394 TID |
| Placeboophthalmic solution. Participants will instill 1 drop in each eye | Drug | Placebo |
Primary outcome
Change from Baseline in Total Corneal Staining Score (TCSS) Using the National Eye Institute (NEI) Scale
Time frame: Week 12
NEI scale (range 0-15; higher scores indicate a worse outcome)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Disease (DED)
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact study manager (07074926091, rlee@huons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Total Corneal Staining Score (TCSS) Using the National Eye Institute (NEI) Scale (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.