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

Primary Purpose

Cerumen Impaction of Both Ears

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Remo-Wax
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerumen Impaction of Both Ears

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • LOR Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remo-Wax

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 11, 2019
Last Updated
May 14, 2019
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03802903
Brief Title
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax
Acronym
Remo-Wax
Official Title
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
April 29, 2019 (Actual)
Study Completion Date
April 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerumen Impaction of Both Ears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remo-Wax
Arm Type
Experimental
Arm Description
Test product will be applied into ear canal for 20-60 minutes.
Intervention Type
Device
Intervention Name(s)
Remo-Wax
Intervention Description
topical treatment
Primary Outcome Measure Information:
Title
Tympanic membrane visuality
Description
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
Time Frame
20-60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained. Male or female patients over 1 year old who have cerumen impaction. 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: Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months. External ear infection. Middle ear infection Past ear surgery. Otorrhea. Temporal bone neoplasm. Presence of known or suspected mastoiditis. 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). Deafness in the contralateral ear (single sided deafness). Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days. Use of hearing aids. Participation in another drug study within 60 days prior to the start of the present study. Predictable poor compliance or inability to communicate well with the investigator.
Facility Information:
Facility Name
LOR Clinic
City
Vilnius
ZIP/Postal Code
LT-06122
Country
Lithuania

12. IPD Sharing Statement

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

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