The Efficacy Of Lyclear (Permethrin 5%) Vs Fusidic Acid1% and Synthomycine 5% for Demodex -Blepharitis Treatment, Prospective-Randomized Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Improvement in symptoms and complaints in group A.
研究概览
简要总结
The study aims to investigate the effect of Permethrin 5% treatment on Signs and symptoms of Demodex-blepharitis in comparison to Synthomycine 5% and Fucithalmic (fusidic acid 1%) .
详细描述
3 arms study. 75 patient total, 25 patients in each group.
Group A (study group) patients will apply facially Permethrin 5% every night for 3 months.
Group B patients will apply on the eyelids Fusidic acid 1% every night for 3 months.
Group C patients will apply on the eyelids Synthomycine 5% every night for 3 months
Follow up Evaluation will be made after one week, one month, two months, three months, 4 months and half a year.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (Age ≥18Y) individuals clinically diagnosed with Demodex- blepharitis.
排除标准
- •Known sensitivity to all study medications or components. Pregnant women and individuals deemed unfit to provide informed consent. Systemic steroid use.
研究组 & 干预措施
Permethrin 5%
Contains permethrin 5% w/w (equivalent to 50 mg/g), formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02% w/w.
干预措施: Permethrin 5% (Drug)
Synthomycine 5%,
Contains chloramphenicol 5%.
干预措施: Synthomycine 5% (Drug)
Fusidic Acid 1%
Contains 1% w/w fusidic acid anhydrous (as the hemihydrates) and 0.011% w/w.
干预措施: Fusidic Acid 1% M/R Eye Drops (Drug)
结局指标
主要结局
Improvement in symptoms and complaints in group A.
时间窗: 2 months
OSDI Questionnaires that describe the severity of the ocular surface disease condition are filled in each visit.
Decrease in demodex infestation in group A (permethrin 5%).
时间窗: 2 months
significant decrease in demodex infestation in comparison to group B and C.
次要结局
未报告次要终点
研究者
Igor Kaiserman
Prof Igor Kaiserman
Barzilai Medical Center