This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
396
After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).
After Randomization(Week 0), Participants will be administered with the durg, QID(4 times in a day, and 1 drop per each times) until end of trial(Week 24).
AJU Pharm Co., Ltd.
Seoul, South Korea
RECRUITINGTotal corneal staining score (TCSS)
TCSS ≥4 at baseline (Total Max score : 15)
Time frame: WEEK 4, 8, 12
LGCSS
Lissamine Green Conjunctival Staining Score(Total score : 0\~18)
Time frame: WEEK 4, 8, 12
TFBUT
Tear Film Break Up Time
Time frame: WEEK 4, 8, 12
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