Clinical Study to Evaluate the Safety and Effectiveness of an Auricular Spray Medical Device Ear Hygiene
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- YSLab
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Skin Irritation
研究概览
简要总结
The goal of this clinical trial is to test the safety and efficacy of a medical device in subjects with cerumen in excess. The main questions it aims to answer are:
- Does the medical device induce skin irritation in the ear canal?
- Does the medical device reduce obstruction of ear canal induced by excessive cerumen?
Participants will use the device in each ear, once a day, every 3 days at home. Researchers will compare the medical device group to a control group who will not use the medical device.
详细描述
Ocean Bio Actif Hygiène de l'oreille is a medical device class IIa indicated for the prevention of the formation of earwax plugs and consequently the pathologies linked to the accumulation of earwax (hearing loss and infection/affection of the external auditory canal).
This clinical investigation is designed to improve the quality and quantity of data available on both the safety and the efficacy of Ocean Bio-Actif, in order to confirm the safety and the efficacy of the product in a post-market environment.
The objective of the current clinical investigation is to confirm the efficacy and safety of topical application to the ear canal of Ocean Bio-Actif.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gender: female and/or male.
- •30 to 40% having age between 3 to 12 yo, 30 to 40% between 13 to 65 yo, 30 to 40% more than 65 yo.
- •Subjects able to use the tested product.
- •Subjects having history of cerumen occlusion more than once a year with or without symptoms (reduction of hearing function, obstruction feeling of the ear canal,..).
- •Subjects having ear help system or regular users of systems such as anti-noise plugs or headsets (only for the 13yo subjects and more).
- •Subjects having a clinical score of ear canal obstruction of 2 or 3 at D0.
排除标准
- •Subjects who had chirurgical act on the mastoïde.
- •Subjects who had severe troubles of the internal ear (severe dizziness, desorientation, nausea).
- •Subjects using regularly a ear spray for washing his/her ears.
- •Subjects having a score of ear canal obstruction at 4 at D
- •Pregnant or nursing woman or planning a pregnancy during the study;
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
- •Subject in a social or sanitary establishment;
- •Subject suspected to be non-compliant according to the investigator's judgment;
- •Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
- •Subject suffering from a severe or progressive disease.
结局指标
主要结局
Skin Irritation
时间窗: Day0 and Day90
To confirm the safety of the device by clinical examination by ENT specialist and scoring of the irritation of the ear canal at Day90 in comparison with basal scoring of irritation at Day0 such as: * 0: no irritation, * 1: slight irritation (located slight erythema and/or dryness), * 2: moderate irritation (clear erythema or dryness which may be visible on the whole treated area), * 3: severe irritation (serious erythema with potential oedema and/or scar).
次要结局
- Hearing Function(Day0 and Day90)
- Ear Canal Obstruction Due to Excessive Earwax(Day0 and Day90)