Dose-finding study of HUC1-394 in people with dry eye disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, interventional trial tests multiple dosing frequencies of the topical agent HUC1-394 against placebo in adults with dry eye disease. Participants will be randomized to receive different doses to identify the regimen that best balances efficacy and safety. Key eligibility includes persistent dry eye symptoms, specific test thresholds, and informed consent. The study is sponsored by Huons Co., Ltd. with Yonsei University Health System, Severance Hospital as the site in Seoul, Korea.

Why it matters

Who can join: the full rules

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

Where it's running

• Yonsei University Health System, Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: study manager
• Email: rlee@huons.com
• Phone: 07074926091

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.