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

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.

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 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