To Evaluate the Efficacy and Safety of HUC3-053 in Patients with Dry Eye Syndrome

Launched by HUONS CO., LTD. · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HUC3-053 to see how effective and safe it is for people suffering from dry eye syndrome. Dry eye syndrome can cause discomfort and vision problems due to a lack of moisture on the eye's surface. In this trial, participants will be randomly assigned to receive either HUC3-053 or a standard treatment called Hyalein Mini Drops, using the drops five to six times a day for 12 weeks.

To be eligible for the trial, participants need to be at least 19 years old and have been experiencing symptoms of dry eye for at least three months. They must also meet certain eye test criteria to confirm their condition. Participants will need to be free of certain eye problems and medications that could affect the results. Throughout the study, participants will receive regular check-ups to monitor their response to the treatment. This trial is currently recruiting, and it welcomes individuals of all genders who meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age over 19
• • 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:
• • The patients with clinically significant ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
• • SBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c\>9%
• • Wearing contact lenses within 72 hr of screening visit
• • Pregnancy or Breastfeeding