Trial Outcomes & Findings for Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax) (NCT NCT02829294)

Last Updated: 2019-10-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

15 and 30 minutes

Results posted on

2019-10-04

Participant Flow

Subject were recruited from the normal clinic population and based on the investigators prior knowledge of treating subjects with the conditions.

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.

Participant milestones

Participant milestones
Measure	Treatment Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The baseline measurements were taking from 19 patients. From these 19 patients, there were a total of 30 ears that met the inclusion criteria for enrollment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=30 ears Subjects that qualify were treated per protocol
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	64.8 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Symptoms related to ear wax impaction - decreased hearing, sensation of fullness, etc	7 Participants n=5 Participants
Number of Participants with quality of life measures affected by ear wax impaction	7 Participants n=5 Participants
Otoscopic measurements of level of ear wax impaction Number of ears with moderate impaction (51-75%)	10 ears n=30 ears • The baseline measurements were taking from 19 patients. From these 19 patients, there were a total of 30 ears that met the inclusion criteria for enrollment.
Otoscopic measurements of level of ear wax impaction Number of ears with severe impaction (76-100%)	20 ears n=30 ears • The baseline measurements were taking from 19 patients. From these 19 patients, there were a total of 30 ears that met the inclusion criteria for enrollment.

PRIMARY outcome

Timeframe: 15 and 30 minutes

Population: Individual ears that met all inclusion/exclusion criteria

Outcome measures

Outcome measures
Measure	Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes n=30 ears E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 1 or 2 treatments of 15 minutes E002 - cerumen removal aid: topical treatment
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
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 outcome

Timeframe: After treatment

Population: 64.8 years +/- 12.3

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)

Outcome measures

Outcome measures
Measure	Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes n=30 ears E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 1 or 2 treatments of 15 minutes E002 - cerumen removal aid: topical treatment
Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients	1 number of ears with reported pruritus

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes n=19 Participants E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 1 or 2 treatments of 15 minutes E002 - cerumen removal aid: topical treatment
Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 Change in decreased hearing	70 % of participants reporting change
Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002 Change in ear itching	90 % of participants reporting change
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
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

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=19 participants at risk Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol
Ear and labyrinth disorders Pruritis of ear	5.3% 1/19 • Number of events 1 • 48 hours post treatment

Additional Information

Joseph Griffin PhD

Eosera Inc

Phone: 8447327929

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60