Dry Eye Disease (DED)
Conditions
Brief 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.
Interventions
DRUGHUC1-394
ophthalmic solution. Participants will instill 1 drop in each eye
DRUGPlacebo
ophthalmic solution. Participants will instill 1 drop in each eye
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Total Corneal Staining Score (TCSS) Using the National Eye Institute (NEI) Scale | Week 12 | NEI scale (range 0-15; higher scores indicate a worse outcome) |
Countries
South Korea
Contacts
CONTACTstudy manager
Outcome results
None listed