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

NCT ID: NCT03802903

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2019-04-29

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.

Conditions

Cerumen Impaction of Both Ears

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remo-Wax

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

Group Type: EXPERIMENTAL

Remo-Wax

Intervention Type: DEVICE

topical treatment

Interventions

Remo-Wax

topical treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LOR Clinic

Vilnius, , Lithuania

Countries

Lithuania

Other Identifiers

3126001

Identifier Type: -

Identifier Source: org_study_id