The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
576
Subjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.
Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.
Kyungpook National University Hospital
Kyungpook, South Korea
Asan Medical Center
Seoul, South Korea
Kim's eye Hospital
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
Time frame: 3 days (Day -3 to Day0)
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Seoul Saint Marry's Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea