Effect of Hypochlorous Acid on Blepharitis Through Ultrasonic Atomization: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- OSDI
研究概览
简要总结
This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
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
- Double (Investigator, Outcomes Assessor)
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
- •Age 18 or older.
- •Anterior or mixed (anterior + posterior) blepharitis.
- •Similar clinical condition of both eyes.
- •A negative urine pregnancy test result for women of childbearing potential
- •Normal lid position and closure
- •Ability to understand and provide informed consent to participate in this study
- •Willingness to follow study instructions and likely to complete all required visits.
排除标准
- •Any ocular surface disease other than blepharitis.
- •Known allergy to hypochlorous acid or boric acid.
- •Eye surgery in the last 6 months.
- •History of Stevens-Johnson syndrome or ocular pemphigoid
- •Ocular trauma in the last 6 months.
- •Use of contact lenses in the last 6 months.
- •Pregnancy or lactation.
- •Daily use of makeup on lashes.
- •Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
- •Pregnant or lactating women
- •Signs of current infection, including fever and current treatment with antibiotics
- •Liver, renal, or hematologic disease
- •The use of any other investigational drug
研究组 & 干预措施
Treatment arm
0.01%hypochlorous acid group
干预措施: 0.01% hypochlorous acid (Drug)
Placebo
eyelid wipes
干预措施: Placebo (Drug)
结局指标
主要结局
OSDI
时间窗: Change from baseline OSDI at 2 weeks
0-100 score based on the ocular surface disease index (OSDI) questionnaire
meibum quality
时间窗: Change from baseline meibum quality score at 2 weeks
Meibum quality were measured by using firm digital pressure applied over 5 lower lid glands. Meibum quality was graded as: grade 0, clear; grade 1, cloudy; grade 2, cloudy with granular debris; and grade 3, thick like toothpaste.
Corneal fluorescein staining
时间窗: Change from baseline corneal fluorescein staining at 2 weeks
scored by Oxford staining score
FBUT
时间窗: Change from baseline FTBUT at 2 weeks
fluorescent tear break up time fluorescein tear film break-up time
次要结局
未报告次要终点