Cerumen Impaction of Both EarsNCT02829294
Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)
A study testing E002 - cerumen removal aid in people with Cerumen Impaction of Both Ears, run by Dr. Joseph Griffin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerumen Impaction of Both Ears
- What is being tested?
- E002 - cerumen removal aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Cerumen Impaction of Both Ears
- Being tested
- E002 - cerumen removal aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E002 - cerumen removal aidDevice
topical treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 15 to 30 minutes Receives: Device: E002 - cerumen removal aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: After treatment
Secondary outcomes (1)
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
Measured: Immediately following 1 or 2 treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerumen Impaction of Both EarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Joseph Griffin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Dr. Joseph Griffin, Eosera Inc
- Investigators
- Joe Griffin, PhD, Study director, Eosera Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829294
- Sponsor's protocol ID
- EOS-002
- Status last verified
- Oct 2019
- First submitted
- 8 Jul 2016
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fullington D, Song J, Gilles A, Guo X, Hua W, Anderson CE, Griffin J. Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen. BMC Ear Nose Throat Disord. 2017 Jun 2;17:5. doi: 10.1186/s12901-017-0038-8. eCollection 2017.
PubMed 28588421
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)
- ClinicalTrials.gov ID
- NCT02829294
- Acronym / sponsor ID
- EOS-002
- Conditions
- Cerumen Impaction of Both Ears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dr. Joseph GriffinIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: E002 - cerumen removal aidE002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 15 to 30 minutes |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E002 - cerumen removal aidtopical treatment | Device | Treatment |
Primary outcome
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.
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)
1 secondary outcome
Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002
Time frame: Immediately following 1 or 2 treatments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28588421Fullington D, Song J, Gilles A, Guo X, Hua W, Anderson CE, Griffin J. Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen. BMC Ear Nose Throat Disord. 2017 Jun 2;17:5. doi: 10.1186/s12901-017-0038-8. eCollection 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Griffin, PhD study director
Eosera Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E002 - cerumen removal aid in people with Cerumen Impaction of Both Ears, run by Dr. Joseph Griffin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.