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

NCT02829294 | Completed Results

• 1 other identifier: EOS-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerumen Impaction of Both Ears

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  After treatment

Secondary Outcomes (1)

• Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002

  Immediately following 1 or 2 treatments

Study Arms (1)

Treatment

EXPERIMENTAL

E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 15 to 30 minutes

Device: E002 - cerumen removal aid

Interventions

E002 - cerumen removal aid DEVICE

topical treatment

Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. Joseph Griffin: lead

Study Sites (1)

Legacy Medical Village

Plano, Texas, 75026, United States

Location

Related Publications (1)

• 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.

  PMID: 28588421 DERIVED

Limitations and Caveats

Single arm, open label evaluation.

Results Point of Contact

• Title: Joseph Griffin PhD
• Organization: Eosera Inc

info@eosera.com

8447327929

Study Officials

• Joe Griffin, PhD

  Eosera Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Scientific Officer

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-10

Locations

US (1)