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

May 14, 2019 updated by: Orion Corporation, Orion Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, LT-06122
        • LOR Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remo-Wax
Test product will be applied into ear canal for 20-60 minutes.
Device: Remo-Wax
topical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tympanic membrane visuality
Time Frame: 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
20-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2019

Primary Completion (Actual)

April 29, 2019

Study Completion (Actual)

April 29, 2019

Study Registration Dates

First Submitted

January 11, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3126001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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