Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease (NCT07656688) | Clinical Trial Compass
RecruitingPhase 2
Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease
South Korea150 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ano…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial for HUC1-394, what do we know so far about its safety profile, and what side effects should I watch for given that it's still in relatively early testing?
2This trial is measuring improvement in Total Corneal Staining Score — can you explain what that means for my specific eyes, and whether my current level of corneal damage would make this a meaningful measure of progress for me?
3Since the trial is actively recruiting right now, how would participating affect my current dry eye treatment — would I need to stop any eye drops or medications I'm already using?
4Would it make more sense for me to try established dry eye treatments first before considering an experimental dose-finding study like this one, or is my condition at a point where this kind of trial might be worth discussing?
5Given that this is a dose-finding study, meaning researchers are still working out the right amount of the drug to use, how might that affect what I'd experience as a participant compared to being on a fixed, proven treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Total Corneal Staining Score (TCSS)