Dose-Finding Study of HUC1-394 in Participants With Dry Eye Disease
ConditionDry Eye Disease (DED)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorHuons Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
HUC1-394
Drugophthalmic solution. Participants will instill 1 drop in each eye
Placebo
Drugophthalmic solution. Participants will instill 1 drop in each eye
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: HUC1-394 BIDExperimental treatment 1 intervention
Group B: HUC1-394 TIDExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Total Corneal Staining Score (TCSS) Using the National Eye Institute (NEI) Scale
NEI scale (range 0-15; higher scores indicate a worse outcome)
Time frame
Week 12Sponsors and contacts
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Source ClinicalTrials.gov