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

Not Applicable

Completed

• Conditions: Cerumen Impaction of Both Ears
• Interventions: Device: Remo-Wax

• Registration Number: NCT03802903
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Study Timeline

• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2019-03-12
• Primary Completion: 2019-04-29
• Study Completion: 2019-04-29
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remo-Wax	Remo-Wax	Test product will be applied into ear canal for 20-60 minutes.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

LOR Clinic; 🇱🇹 Vilnius, Lithuania