To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome
NCT ID: NCT06388070
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
297 participants
INTERVENTIONAL
2024-05-20
2025-03-21
Brief Summary
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After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks.
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Detailed Description
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During a 2-week study run-in period prior to randomization, all subjects will receive rescue drug bilaterally up to 4 times a day. Randomization will then occur as 1:1 where patients will be assigned to receive HUC3-053 or Hyalein Mini Drops given bilaterally five to six times a day. The treatment period is 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HUC3-053
Participants received "HUC3-053" drops in each eye five to six times a day for 12 weeks.
HUC3-053
drops in each eye five to six times a day for 12 weeks
Hyalein Mini Drops
Participants received "Hyalein Mini Drops" in each eye five to six times a day for 12 weeks.
Hyalein Mini Drops
drops in each eye five to six times a day for 12 weeks.
Interventions
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HUC3-053
drops in each eye five to six times a day for 12 weeks
Hyalein Mini Drops
drops in each eye five to six times a day for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Volunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.
* Corneal staining score(Oxford grading) ≥ 2 and Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min) and TBUT test ≤10 and OSDI (Ocular Surface Disease Index) ≥ 23 in at least one of both eyes
* Best corrected visual acuity ≥ 0.2 in both eyes at Screening and Randomization Visit
Exclusion Criteria
* SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c\>9%
* Wearing contact lenses within 72 hr of screening visit
* Pregnancy or Breastfeeding
19 Years
ALL
No
Sponsors
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Huons Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chul Young Choi
Role: PRINCIPAL_INVESTIGATOR
Gangbuk Samsung Hospital
Locations
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Gangbuk Samsung Hospital
Seoul, Jongno-gu, South Korea
Countries
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Other Identifiers
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HUC3-053
Identifier Type: -
Identifier Source: org_study_id
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