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

Cerumen Impaction of Both Ears Clinical Trial

— Remo-Wax  

Official title:

Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802903
• Other study ID #: 3126001
• Status: Completed
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: April 29, 2019

Study information

• Verified date: May 2019
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 29, 2019
• Est. primary completion date: April 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerumen Impaction of Both Ears

Intervention

Device:
• Remo-Wax
topical treatment

Locations

Country	Name	City	State
Lithuania	LOR Clinic	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tympanic membrane visuality	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	20-60 minutes