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NCT05743764
HU007 in Patients With Dry Eye Syndrome
Conditions: Dry Eye Disease
Sex: All
Ages: 19 Years – N/A
Phase: PHASE3
Enrollment: 328
Sponsor: Huons Co., Ltd.
Summary
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops Controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome
Eligibility Criteria
Inclusion CriteriaAge over 19Corneal 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 eyesVolunteer who have had more than one symptom of dry eye disease for at least 3 month before screening visit.Exclusion Criteria:The patients with clinically significant ocular disorders affected the test resultCurrent or recent patients used dry eye syndrome medications (topical or systemic) that may affect the statusSBP ≥140mmHg or DBP ≥ 90mmHg or HbA1c>9%Wearing contact lenses within 72 hr of screening visitPregnancy or Breastfeeding
Source: ClinicalTrials.gov (NCT05743764). StuddyBuddy aggregates publicly available trial information.