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

October 3, 2019 updated by: Dr. Joseph Griffin
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Texas
      • Plano, Texas, United States, 75026
        • Legacy Medical Village

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or non-pregnant females ≥ 40 years of age at enrollment;
  2. 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];
  3. Willingness to participate in the study; or
  4. Mental aptitude to provide verbal and/or written informed consent without the aid of another.

Exclusion Criteria:

  1. 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);
  2. Presence of a tympanostomy tube at any time during the previous 12 months;
  3. Presence of a non-intact tympanic membrane (TM);
  4. Presence of a known or suspected ear infection;
  5. Presence of known or suspected mastoiditis;
  6. 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
  7. 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).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 15 to 30 minutes
Device: E002 - cerumen removal aid
topical treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 15 and 30 minutes
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
Time Frame: After treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002
Time Frame: Immediately following 1 or 2 treatments
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Joseph Griffin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Joe Griffin, PhD, Eosera Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EOS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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