Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)

Study Overview
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Brief Summary
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This is a prospective, open-labeled clinical trial. Subjects that qualify for enrollment and provide informed consent will be treated with a novel topical cerumen (earwax) removal product. The primary goal of this pilot study is to gain an understanding of the safety and efficacy of this novel product.

Detailed Description
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This is a single center, single-arm, open-label trial. Approximately 30 evaluable ears will be enrolled that have at least 50% cerumen impaction. All ears/subjects will receive at least a single dose (approximately 1 - 2 mL) of the test product applied topically in the study ear canal. The test product will be supplied from a qualified compounding pharmacy that receives a by-subject prescription from the investigator. The subject will be dosed with the head tilted in order to keep the test product in the ear canal for 15 minutes. At 5 and 10 minutes, subjects will be instructed to move their jaw up and down (and side to side) a few times and, manipulate/massage the ear canal by pressing between jawbone and ear lobe with a rotating motion for 10 seconds, which may aid in distribution of the test product in the ear canal. Fifteen minutes after product instillation, it will be removed by having the subject tilt the head over a disposable container to catch the solution. The ear canal will be irrigated (low pressure) with warm water and, the evaluator will try to visualize the tympanic membrane using an otoscope (before and after lavage). The amount (change in area, volume and depth) of the tympanic membrane that can be visualized and the categorization of cerumen impaction (according to a 5 point scale) is the primary efficacy parameter of this study. Efficacy will also be assessed using subjective questions (improvement and change in symptoms) that will be asked by the study staff and documented prior to the subject having any knowledge of the otoscope results (visualization of TP).

Official Title
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Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)

Conditions
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Cerumen Impaction of Both Ears

Intervention / Treatment
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* Device: E002 - cerumen removal aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or non-pregnant females ≥ 40 years of age at enrollment; 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]; Willingness to participate in the study; or Mental aptitude to provide verbal and/or written informed consent without the aid of another. Exclusion Criteria: Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study (has been accustomed to birth control and will continue it up to and including Visit 2); Presence of a tympanostomy tube at any time during the previous 12 months; Presence of a non-intact tympanic membrane (TM); Presence of a known or suspected ear infection; Presence of known or suspected mastoiditis; Use of any ototopical drug or OTC product or earwax-removal product (with the exception of water or physiologic saline) during the preceding 3 days; or 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 seborrhea).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 15 to 30 minutes | Device: E002 - cerumen removal aid<br>* topical treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product | Cerumen impaction will be graded following 15 and 30 minutes after using the test product in the external ear canal. Cerumen impaction is graded by the % of the ear drum is visible using an otoscope. Grade 5 (severe) = 76-100% of the ear drum is obstructed from view. Grade 4 (moderate) = 51-75% of the ear drum is obstructed from view. Grade 3 (mild) = 26-50% of the ear drum is obstructed from view. Grade 2 = 3-25% of the ear drum is obstructed from view. Grade 1 (normal) = less than 3% of the ear drum is obstructed from view. | 15 and 30 minutes | 
| Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients | Ear canal specific safety evaluation, measured by physician, during the course of treatment up to 48 hours post treatment and collection of adverse events (related and non-related) | After treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 | Collect symptom information prior to and post treatment with the novel test solution designed to help clean and clear the ear canal of debris including cerumen | Immediately following 1 or 2 treatments |