Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT02829294
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@eosera.com', 'phone': '8447327929', 'title': 'Joseph Griffin PhD', 'organization': 'Eosera Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Single arm, open label evaluation.'}}, 'adverseEventsModule': {'timeFrame': '48 hours post treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritis of ear', 'notes': 'Itching reported following treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'ears', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes', 'description': 'E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 1 or 2 treatments of 15 minutes\n\nE002 - cerumen removal aid: topical treatment'}], 'classes': [{'title': '% of Grade 1 (normal) after 1 treatment (15 mins)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'ears', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}]}]}, {'title': '% of Grade 1 (normal) after 2 treatments (30 mins)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'ears', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 and 30 minutes', 'description': '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.', 'unitOfMeasure': 'percentage of ears', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ears', 'denomUnitsSelected': 'ears', 'populationDescription': 'Individual ears that met all inclusion/exclusion criteria'}, {'type': 'PRIMARY', 'title': 'Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'ears', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes', 'description': 'Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After treatment', 'description': '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)', 'unitOfMeasure': 'number of ears with reported pruritus', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'ears', 'denomUnitsSelected': 'ears', 'populationDescription': '64.8 years +/- 12.3'}, {'type': 'SECONDARY', 'title': 'Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ears Treated With E002 for 1 or 2 Treatments of 15 Minutes', 'description': 'Subjects with either one or 2 ears that met the inclusion/exclusion criteria were treated with test product per protocol'}], 'classes': [{'title': 'Change in decreased hearing', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Change in ear itching', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Change in feelings of fullness', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Change in water trapping or cracking', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately following 1 or 2 treatments', 'description': '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', 'unitOfMeasure': '% of participants reporting change', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 19 participants and of these 19 participants there were 30 ears that met the inclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Subjects that meet the inclusion/exclusion criteria were treated with test product per protocol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject were recruited from the normal clinic population and based on the investigators prior knowledge of treating subjects with the conditions.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}, {'units': 'ears', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Subjects that qualify were treated per protocol'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients greater than or equal to 40 years of age', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '12.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects were asked if they were male or female', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects were asked to describe their ethnicity.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Symptoms related to ear wax impaction - decreased hearing, sensation of fullness, etc', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Number of Participants with quality of life measures affected by ear wax impaction', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Criteria used to assess this baseline measure on Quality of Life included measures of decreased hearing, feeling of fullness in the ear, ringing or noises in the ear (tinnitus), ear itching, water trapping or cracking noise after swimming or shower, ear irritation/discomfort, earache, tingling in the ear or ear pain.', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Otoscopic measurements of level of ear wax impaction', 'classes': [{'title': 'Number of ears with moderate impaction (51-75%)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Number of ears with severe impaction (76-100%)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The level of ear wax impaction was graded using a clinical score based on how visible the tympanic membrane (ear drum) was when viewed with an otoscope as follows: A score of 1 (normal) means less than 3% of the ear drum was obstructed from view. A score of 2 (minimal) means that from 3 to 25% of the ear drum was obstructed from view by debris/ear wax. A score of 3 (mild) means that 26 to 50% of the ear drum was obstructed from view. A score of 4 (moderate) means 51 to 75% of the ear drum was obstructed from view. A score of 5 (severe) means 76-100% of the ear drum was obstructed from view.', 'unitOfMeasure': 'ears', 'denomUnitsSelected': 'ears', 'populationDescription': '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.'}], 'typeUnitsAnalyzed': 'ears', 'populationDescription': 'There were 19 participants and of these 19 participants there were 30 ears that individually met the inclusion criteria.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2016-07-08', 'resultsFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-03', 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '15 and 30 minutes', 'description': '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.'}, {'measure': 'Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients', 'timeFrame': 'After treatment', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002', 'timeFrame': 'Immediately following 1 or 2 treatments', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerumen Impaction of Both Ears']}, 'referencesModule': {'references': [{'pmid': '28588421', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or non-pregnant females ≥ 40 years of age at enrollment;\n2. 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\\];\n3. Willingness to participate in the study; or\n4. Mental aptitude to provide verbal and/or written informed consent without the aid of another.\n\nExclusion Criteria:\n\n1. 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);\n2. Presence of a tympanostomy tube at any time during the previous 12 months;\n3. Presence of a non-intact tympanic membrane (TM);\n4. Presence of a known or suspected ear infection;\n5. Presence of known or suspected mastoiditis;\n6. 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\n7. 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).'}, 'identificationModule': {'nctId': 'NCT02829294', 'briefTitle': 'Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eosera Inc'}, 'officialTitle': 'Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)', 'orgStudyIdInfo': {'id': 'EOS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'E002 - cerumen removal aid will be placed into the ear canal of enrolled subjects for 15 to 30 minutes', 'interventionNames': ['Device: E002 - cerumen removal aid']}], 'interventions': [{'name': 'E002 - cerumen removal aid', 'type': 'DEVICE', 'description': 'topical treatment', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75026', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Legacy Medical Village', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Joe Griffin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eosera Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Joseph Griffin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Scientific Officer', 'investigatorFullName': 'Dr. Joseph Griffin', 'investigatorAffiliation': 'Eosera Inc'}}}}