Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax

Orion Pharma

Status: Completed

Conditions: Cerumen Impaction of Both Ears

Treatments: Device: Remo-Wax

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802903

3126001

Details and patient eligibility

About

The study evaluates if Remo-Wax ear drops can soften impacted earwax.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

Remo-Wax

Experimental group

Description:

Test product will be applied into ear canal for 20-60 minutes.

Treatment:

Device: Remo-Wax