Effect of Topical Besifloxacin on Ocular Surface Bacterial Microbiota Prior to Cataract Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of positive cultures before and after treatment in each arm
研究概览
简要总结
Describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.
详细描述
Randomized double-blind clinical trial. Study carried out in a single center between January and April 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two groups. The first group received placebo (hydroxypropylmethylcellulose drops) while the second group received 0.6% besifloxacin drops four times a day for 3 days. All of them had a conjunctival cul-de-sac culture before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 18 years of age scheduled for cataract surgery in the established study period.
- •Subjects physically and mentally capable of applying the eye drops or having a person available to help in the correct administration of the eye drops 4 times a day.
排除标准
- •- Active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and / or conjunctivitis.
- •Known allergy or any contraindication to the use of quinolones or any of the components of the drugs.
研究组 & 干预措施
Besifloxacin
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
干预措施: Besifloxacin Ophthalmic (Drug)
Hydroxypropyl methylcellulose
1 DROP 4 TIMES A DAY FOR 3 DAYS PRIOR SURGERY
干预措施: Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution (Drug)
结局指标
主要结局
Percentage of positive cultures before and after treatment in each arm
时间窗: Through study completion, an average of 1 year
A conjunctival cul-de-sac sample will be taken before starting treatment and before surgery, which will be cultured on 3 different media types: Blood, Chocolate and Sabouraud agar.
次要结局
未报告次要终点