Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
- Registration Number
- NCT02573610
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 576
Inclusion Criteria
- Those who are scheduled for cataract surgery
Exclusion Criteria
- Those who with suspected ocular infections based on clinical findings in the study eye.
- Those who have any eye disease other than cataract which requires treatment in the target eye.
- Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine)
- Those who need to wear contact lenses during the study period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE-108 DE-108 High concentration / Antibacterial Ophthalmic Solution Levofloxacin 0.5% Levofloxacin 0.5% Low concentration / Antibacterial Ophthalmic Solution
- Primary Outcome Measures
Name Time Method Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) 3 days (Day -3 to Day0)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Kim's eye Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Kyungpook, Korea, Republic of
Seoul Saint Marry's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of