Cerumen Impaction of Both Ears
Conditions
Brief 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.
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).
Interventions
DEVICEE002 - cerumen removal aid
topical treatment
Sponsors
Dr. Joseph Griffin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 | 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 |
Countries
United States
Participant flow
Recruitment details
Subject were recruited from the normal clinic population and based on the investigators prior knowledge of treating subjects with the conditions.
Pre-assignment details
Subjects were pre-screened. If subjects agreed to participate, treatment was scheduled. On the treatment day, subjects were re-screened to ensure inclusion/exclusion criteria were met. Subjects were consented and then proceeded to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects that qualify were treated per protocol | 19 |
| Treatment Subjects that qualify were treated per protocol | 30 |
| Total | 49 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 64.8 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Participants with quality of life measures affected by ear wax impaction | 7 Participants |
| Otoscopic measurements of level of ear wax impaction Number of ears with moderate impaction (51-75%) | 10 ears |
| Otoscopic measurements of level of ear wax impaction Number of ears with severe impaction (76-100%) | 20 ears |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 15 Participants |
| Symptoms related to ear wax impaction - decreased hearing, sensation of fullness, etc | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 1 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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
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.
Time frame: 15 and 30 minutes
Population: Individual ears that met all inclusion/exclusion criteria
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product | % of Grade 1 (normal) after 1 treatment (15 mins) | 53.3 percentage of ears |
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product | % of Grade 1 (normal) after 2 treatments (30 mins) | 85.7 percentage of ears |
Primary
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)
Time frame: After treatment
Population: 64.8 years +/- 12.3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients | 1 number of ears with reported pruritus |
Secondary
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
Time frame: Immediately following 1 or 2 treatments
Population: There were 19 participants and of these 19 participants there were 30 ears that met the inclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 | Change in decreased hearing | 70 % of participants reporting change |
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 | Change in ear itching | 90 % of participants reporting change |
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 | Change in feelings of fullness | 90 % of participants reporting change |
| Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes | Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 | Change in water trapping or cracking | 80 % of participants reporting change |