跳至主要内容
临床试验/NCT07451678
NCT07451678已完成4 期

Treatment of Blepharitis Induced by Demodex Folliculorum Through Eyelid Cleansing With Wipes Containing Topical Chlorhexidine

Instituto de Oftalmología Fundación Conde de Valenciana1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年7月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
39
试验地点
1
主要终点
Reduction in Demodex folliculorum count per eyelash

研究概览

简要总结

This study employed an experimental, prospective, longitudinal, before-and-after design to evaluate the efficacy of topical chlorhexidine wipes in treating blepharitis.

The investigation focused on assessing signs and symptoms associated with Demodex Folliculorum blepharitis, including telangiectasia, ocular irritation, collarettes, foreign body sensation, tearing, eyelid erythema, and dry eye. Each subject underwent an assessment of the Demodex Folliculorum infection index through the epilation of four eyelashes, followed by direct visualization using optical microscopy. Additionally, the number of eyelashes with collarettes was categorized and graded as follows: Grade 0: 0-2 eyelashes per eyelid with collarettes; Grade 1: 3-10 eyelashes per eyelid with collarettes; Grade 2: ≥10 to ≤1/3; Grade 3: ≥1/3 - ≤2/3; Grade 4: ≥2/3 of eyelashes per eyelid with collarettes.

Participants applied topical chlorhexidine wipes twice daily, in the morning and evening, to cleanse the eyelash area of both eyelids over a period of four weeks. A follow-up assessment was conducted at four weeks, during which another Demodex test was performed to ascertain the presence of the microorganism. At week ten, the same signs and symptoms evaluated in the initial assessment were re-evaluated for follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Age ≥ 18 years
  • Clinical diagnosis of Demodex folliculorum blepharitis
  • Presence of eyelash collarettes on slit-lamp examination
  • Positive identification of Demodex folliculorum by epilation of 4 upper and 4 lower eyelashes per eyelid and visualization under light microscopy
  • Willingness to use chlorhexidine eyelid wipes as instructed for 8 weeks

排除标准

  • Use of topical or systemic antiparasitic treatment within the past 6 weeks
  • Use of topical ophthalmic antibiotics or anti-inflammatory medication within the past 6 weeks
  • Known allergy or hypersensitivity to chlorhexidine
  • Pregnancy or breastfeeding

研究组 & 干预措施

Treatment of Blepharitis by Demodex Folliculorum Group

Experimental

The investigation focused on assessing signs and symptoms associated with Demodex Folliculorum blepharitis, including telangiectasia, ocular irritation, collarettes, foreign body sensation, tearing, eyelid erythema, and dry eye.

干预措施: Eyelid Cleansing with Wipes Containing Topical Chlorhexidine (Drug)

结局指标

主要结局

Reduction in Demodex folliculorum count per eyelash

时间窗: Baseline and 8 weeks

Mean number of Demodex folliculorum mites per eyelash (mites/lash) assessed by epilation of 4 eyelashes from the upper eyelid and 4 eyelashes from the lower eyelid and examination under light microscopy at 40× magnification. The outcome will be reported as the change in mean mites/lash from baseline to 8 weeks after treatment with chlorhexidine eyelid wipes.

次要结局

  • Change in eyelash collarette grade(Baseline and 8 weeks)
  • Proportion of participants by Ocular Surface Disease Index (OSDI) severity category(Baseline and 8 weeks)

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验