Status:
COMPLETED
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Cerumen Impaction of Both Ears
Eligibility:
All Genders
1+ years
Phase:
NA
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. Subjec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03802903
Start Date
March 12 2019
End Date
April 29 2019
Last Update
May 15 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LOR Clinic
Vilnius, Lithuania, LT-06122