Excessive Ear Wax
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHEREar Hygiene
2 sprays in each ear, every 3 days at home
Sponsors
YSLab
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Gender: female and/or male. * Age: 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.
Exclusion criteria
* 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 D0. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ear Canal Obstruction Due to Excessive Earwax | Day0 and Day90 | To confirm the efficacy/performance of the device for the prevention of ear obstruction in comparison to baseline (Day0) and between groups using the scoring of the obstruction of ear canal by the Investigator: 0: no obstruction - normal and/or no significant presence of cerumen in the ear canal. The membrane is clearly visible. 1. \<25% minimal, very little and mostly insignificant impacted cerumen. The tympanic membrane is visible, but with still a little bit cerumen. 2. 25-50% mild, some excessive impacted cerumen causing partial occlusion of the ear canal. The tympanic membrane is not entirely visible, quite difficult to see. 3. 50-75% moderate, moderate and excessive impacted cerumen causing partial occlusion of the ear canal. Partial to very little of the tympanic membrane is visible. 4. 75-100% severe, severe and excessive impacted cerumen causing partial or complete occlusion of the ear canal. Little if any of the tympanic membrane is visible. |
| Hearing Function | Day0 and Day90 | Secondary aims: EFFICACY/PERFORMANCE PREVENTION for investigational device and for control group, in comparison to the baseline (Day0) using an audiogram (only for subjects more than 6). Hearing function was assessed in patients on day 0 (D0) and day 90 (D90). The mean difference in hearing function (D90 - D0), expressed in decibels (dB), was reported in a data table. A mean difference greater than +5 dB is considered a gain in hearing function, while a mean difference less than -5 dB is considered a loss in hearing function. A difference in hearing function within the range \[-5 dB; +5 dB\] is considered to indicate no effect on hearing function. |
Countries
Poland
Participant flow
Recruitment details
Recruitment at the investigational sites
Pre-assignment details
Each subject having signed a consent form will be assigned a screening subject number according to his/her chronological order of arrival in the study.
Participants by arm
| Arm | Count |
|---|---|
| Auricular Spray Subjects using the medical device under investigation: 2 sprays in each ear, every 3 days at home.
Ear Hygiene: 2 sprays in each ear, every 3 days at home | 64 |
| Control Subjects not using any spray (can use ear drops in case of discomfort or pain) | 35 |
| Total | 99 |
Baseline characteristics
| Characteristic | Auricular Spray | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 15 Participants | 40 Participants |
| Age, Categorical >=65 years | 16 Participants | 9 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 11 Participants | 34 Participants |
| Age, Continuous | 36.2 years | 35.6 years | 36.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 64 Participants | 35 Participants | 99 Participants |
| Region of Enrollment Poland | 64 participants | 35 participants | 99 participants |
| Sex: Female, Male Female | 42 Participants | 22 Participants | 64 Participants |
| Sex: Female, Male Male | 22 Participants | 13 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 35 |
| other Total, other adverse events | 1 / 64 | 0 / 35 |
| serious Total, serious adverse events | 0 / 64 | 0 / 35 |
Outcome results
Primary
Skin Irritation
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).
Time frame: Day0 and Day90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Spray | Skin Irritation | Irritation at D0 | 0.22 score on a scale | Standard Deviation 0.45 |
| Auricular Spray | Skin Irritation | Irritation D90 | 0.13 score on a scale | Standard Deviation 0.49 |
| Control | Skin Irritation | Irritation at D0 | 0.20 score on a scale | Standard Deviation 0.41 |
| Control | Skin Irritation | Irritation D90 | 0.11 score on a scale | Standard Deviation 0.32 |
Secondary
Ear Canal Obstruction Due to Excessive Earwax
To confirm the efficacy/performance of the device for the prevention of ear obstruction in comparison to baseline (Day0) and between groups using the scoring of the obstruction of ear canal by the Investigator: 0: no obstruction - normal and/or no significant presence of cerumen in the ear canal. The membrane is clearly visible. 1. \<25% minimal, very little and mostly insignificant impacted cerumen. The tympanic membrane is visible, but with still a little bit cerumen. 2. 25-50% mild, some excessive impacted cerumen causing partial occlusion of the ear canal. The tympanic membrane is not entirely visible, quite difficult to see. 3. 50-75% moderate, moderate and excessive impacted cerumen causing partial occlusion of the ear canal. Partial to very little of the tympanic membrane is visible. 4. 75-100% severe, severe and excessive impacted cerumen causing partial or complete occlusion of the ear canal. Little if any of the tympanic membrane is visible.
Time frame: Day0 and Day90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Auricular Spray | Ear Canal Obstruction Due to Excessive Earwax | Obstruction at D0 | 2.33 score on a scale | Standard Deviation 0.48 |
| Auricular Spray | Ear Canal Obstruction Due to Excessive Earwax | Obstruction at D90 | 1.19 score on a scale | Standard Deviation 1.16 |
| Control | Ear Canal Obstruction Due to Excessive Earwax | Obstruction at D0 | 2.29 score on a scale | Standard Deviation 0.46 |
| Control | Ear Canal Obstruction Due to Excessive Earwax | Obstruction at D90 | 1.97 score on a scale | Standard Deviation 0.92 |
Secondary
Hearing Function
Secondary aims: EFFICACY/PERFORMANCE PREVENTION for investigational device and for control group, in comparison to the baseline (Day0) using an audiogram (only for subjects more than 6). Hearing function was assessed in patients on day 0 (D0) and day 90 (D90). The mean difference in hearing function (D90 - D0), expressed in decibels (dB), was reported in a data table. A mean difference greater than +5 dB is considered a gain in hearing function, while a mean difference less than -5 dB is considered a loss in hearing function. A difference in hearing function within the range \[-5 dB; +5 dB\] is considered to indicate no effect on hearing function.
Time frame: Day0 and Day90
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Spray | Hearing Function | 1.07 dB | Standard Deviation 5.69 |
| Control | Hearing Function | 0.26 dB | Standard Deviation 4.37 |