Clinical trial NCT04653662: Earol Madrid Study
Official title: Multi-center, Open-label, Non-randomized, Single-arm Clinical Study to Assess the Safety and Performance of Earol® in Adult Patients With Ear Wax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerumen Impaction of Both Ears
Keywords: Ear Wax Removal
Ear Wax
Earol
Olive oil
Cerumen
Impaction
Lead sponsor: HL Healthcare Ltd
Sponsor class: INDUSTRY
Collaborators: name: AKRN Scientific Consulting, S.L.
First posted: 2020-12-04
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Accumulation of ear wax in the external ear canal is a common pathology. The presence of ear wax not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections.

Removal of ear wax is facilitated using a variety of cerumenolytics, or ear wax solvents. The current study is designed to evaluate the safety and the cerumenolytic effects of the Earol product, when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure. This study is designed to be conducted in the primary care setting as a prospective clinical trial.

A detailed literature review has been conducted to provide a background summary of relevant information on the disease/pathology, other available treatment options and the pre-clinical testing and clinical research that has been conducted to date on the intended population or related populations and/or the device.

The aim for conducting this clinical investigation is to perform a PMCF to evaluate the safety and performance of Earol. Although there are alternative methods for ear wax removal, Earol represents a simple method based on natural ingredients (olive oil) which aids the removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal (E.g. reducing itching and irritation).


Eligibility criteria: Inclusion Criteria:

* Subject must be willing to provide written informed consent prior to any clinical investigation related procedure;
* Male or female patients over 18-year-old;
* Presence of ear wax in both ear canals with a minimum of \> 50% ear wax blockage in at least one ear (level 4) and \> 25% blockage in the contralateral ear (level 3) as assessed using the TMVSS;
* Subject must be willing and able to perform all the visits, follow the PI instructions and complete the follow-up of the study.

Exclusion Criteria:

* Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study;
* Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period;
* Presence of other anatomic or comorbid conditions (e.g. ear eczema or seborrhea), or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness;
* Presence or history of a tympanic membrane perforation or tympanostomy tubes at any time during the previous 6 months;
* Presence or history of a known or suspected ear infection (i.e. otitis externa or otitis interna) in the previous 2 months;
* Presence of a known or suspected chronic suppurative otitis media;
* Presence or history of a known or suspected keratosis obturans;
* Presence of known or suspected mastoiditis;
* Use of any ototopical drug or OTC product or ear wax-removal product (except for water or physiologic saline) during the preceding 3 days;
* Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions;
* Temporal bone neoplasm.

Primary outcomes:
measure: SAEs and AEs reported
timeFrame: Day 6
Secondary outcomes:
measure: Cerumen blockage assesment
timeFrame: Day 0 and Day 6
measure: Ear clinical symptoms
timeFrame: Day 0 and Day 6
measure: Patient clinical symptoms
timeFrame: Day 0 and Day 6
measure: SAEs and AEs reported
timeFrame: Day 12
measure: Patient clinical symptom and ease-of-use
timeFrame: Day 6
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital QuironSalud Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Marbella
country: Spain
facility: Hospital QuironSalud Marbella
city: Sevilla
country: Spain
facility: Hospital Quirónsalud Infanta Luisa
Study officials:
References: