This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, Phase III Study to evaluate the efficacy and safety of HU007 eye drops in patients With dry eye syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
Cyclosporine 0.02% with Trehalose 3%
Cyclosporine 0.05%
Seoul National University Bundang Hospital
Seongnam, South Korea
Change from baseline in corneal staining score-Oxford grading
Change from baseline in corneal staining score-Oxford grading at Week 12
Time frame: Week 12
Change from baseline in corneal staining score-Oxford grading
Change from baseline in corneal staining score-Oxford grading at Week 4, 8
Time frame: Week 4, 8
Change from baseline in conjunctival staining score-Oxford grading
Change from baseline in conjunctival staining score-Oxford grading at Week 4, 8, 12
Time frame: Week 4, 8, 12
Change from baseline in strip meniscometry
Change from baseline in strip meniscometry at Week 4, 8, 12
Time frame: Week 4, 8, 12
Change from baseline in Tear film break-up time
Change from baseline in Tear film break-up time at Week 4, 8, 12
Time frame: at Week 4, 8, 12
Change from Baseline of Standard patient evaluation of eye dryness questionnaire
Change from Baseline of Standard patient evaluation of eye dryness questionnaire at Week 4, 8, 12
Time frame: at Week 4, 8, 12
Time to achieve 100% clearance on the corneal staining score
Time to achieve 100% clearance on the corneal staining score
Time frame: upto week 12
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