HU007 in Patients with Dry Eye Syndrome

Launched by HUONS CO., LTD. · Feb 22, 2023

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Age over 19
• • 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 in at least one of both eyes
• • Patients who have had more than one symptom of dry eye disease for at least 3 month before screening visit
• • Best corrected visual acuity of 0.2 or higher in both eyes
• • Those who voluntarily decided to participate and agreed in writing to comply with the precautions
• Exclusion Criteria:
• • 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 prior to screening visit or during clinical trial
• • Pregnancy or Breastfeeding
• • Patient with a history of glaucoma, or intraocular pressure of 25mmHg or higher at least one eyes
• • Patient with autoimmune disease (e.g. sjogren's syndrome)
• • Patients with a history of corneal transplant or neurotrophic keratitis