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

NCT03802903 | Completed

• 1 other identifier: 3126001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerumen Impaction of Both Ears

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Remo-Wax

EXPERIMENTAL

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

Device: Remo-Wax

Interventions

Remo-Wax DEVICE

topical treatment

Remo-Wax

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

LOR Clinic

Vilnius, LT-06122, Lithuania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 14, 2019
• Study Start: March 12, 2019
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

LI (1)