The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.
This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial. Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
1 or 2 drops twice a day at 12 hour interval for 12 weeks
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Busan National University Hospital
Busan, Busan, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, Seoul, South Korea
Korea University Anam Hospital
Seoul, Seoul, South Korea
Corneal staining
Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time frame: up to 12 weeks
Ocular Surface Disease Index(OSID)
Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.
Time frame: 0 day, 4 weeks and 12 weeks
Tear Breakup Time(TBUT)
Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time frame: 0 day, 4 weeks and 12 weeks
Schirmer score
Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time frame: 0 day, 4 weeks and 12 weeks
Drug compliance
Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time frame: 0 day, 4 weeks and 12 weeks
DEWS(Dry Eye WorkShop) level
Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
Time frame: 0 day, 4 weeks and 12 weeks
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Asan Medical Center
Seoul, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea