Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Tympanic membrane visuality
研究概览
简要总结
The study evaluates if Remo-Wax ear drops can soften impacted earwax.
详细描述
This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Male or female patients over 1 year old who have cerumen impaction.
- •Presence of excessive or impacted cerumen [excessive or impacted cerumen is identified as causing partial (> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane.
排除标准
- •Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions.
- •History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months.
- •External ear infection.
- •Middle ear infection
- •Past ear surgery.
- •Temporal bone neoplasm.
- •Presence of known or suspected mastoiditis.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (e.g. ear eczema or seborrhoea, ear canal stenosis, exostoses).
- •Deafness in the contralateral ear (single sided deafness).
- •Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days.
- •Use of hearing aids.
- •Participation in another drug study within 60 days prior to the start of the present study.
- •Predictable poor compliance or inability to communicate well with the investigator.
研究组 & 干预措施
Remo-Wax
Test product will be applied into ear canal for 20-60 minutes.
干预措施: Remo-Wax (Device)
结局指标
主要结局
Tympanic membrane visuality
时间窗: 20-60 minutes
Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application. Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal
次要结局
未报告次要终点