Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Dry Eye Disease (DED)
In brief
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.
Key facts
- Study ID
- NCT07656688
- Run by
- Huons Co., Ltd.
- People needed
- 150
- Starts
- 2026-07-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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