Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60,000
- 试验地点
- 2
- 主要终点
- Endophthalmitis after cataract surgery
研究概览
简要总结
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis
详细描述
Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •visually significant cataracts
排除标准
- •allergy to fluoroquinolones, cobalamin (B12)
研究组 & 干预措施
Placebo group
Intracameral injection of placebo after cataract surgery
干预措施: Placebo (Drug)
Treatment group
Intracameral injection of moxifloxacin solution after cataract surgery
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Endophthalmitis after cataract surgery
时间窗: Subjects will undergo eye examinations at one day, one week, and one month post-operatively
Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.
次要结局
未报告次要终点
研究者
Jason Ahee, M.D.
Medical Director
Zion Therapeutics, LLC