N/A
N=19
Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)
Cerumen Impaction of Both Ears
Bottom Line
View on ClinicalTrials.gov: NCT02829294 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product — 53.3; 85.7 percentage of ears
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- E002 - cerumen removal aid (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Dr. Joseph Griffin
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product |
53.3; 85.7 | — |
| PRIMARY Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients |
1 | — |
| SECONDARY Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 |
70; 90; 90; 80 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02829294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.