NCT02573610已完成3 期
A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 576
- 试验地点
- 6
- 主要终点
- Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are scheduled for cataract surgery
排除标准
- •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
研究组 & 干预措施
DE-108
Experimental
High concentration / Antibacterial Ophthalmic Solution
干预措施: DE-108 (Drug)
Levofloxacin 0.5%
Active Comparator
Low concentration / Antibacterial Ophthalmic Solution
干预措施: Levofloxacin 0.5% (Drug)
结局指标
主要结局
Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
时间窗: 3 days (Day -3 to Day0)
次要结局
未报告次要终点
研究者
研究点 (6)
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