Cerumen Impaction of Both Ears
Conditions
Brief summary
The study evaluates if Remo-Wax ear drops can soften impacted earwax.
Detailed description
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.
Interventions
DEVICERemo-Wax
topical treatment
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained. 2. Male or female patients over 1 year old who have cerumen impaction. 3. 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.
Exclusion criteria
1. Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions. 2. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months. 3. External ear infection. 4. Middle ear infection 5. Past ear surgery. 6. Otorrhea. 7. Temporal bone neoplasm. 8. Presence of known or suspected mastoiditis. 9. 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). 10. Deafness in the contralateral ear (single sided deafness). 11. Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days. 12. Use of hearing aids. 13. Participation in another drug study within 60 days prior to the start of the present study. 14. Predictable poor compliance or inability to communicate well with the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tympanic membrane visuality | 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 |
Countries
Lithuania
Outcome results
None listed