Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT02511561
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2015-07-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OTO-201 for the Treatment of Otitis Externa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010032', 'term': 'Otitis Externa'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@otonomy.com', 'phone': '1-800-826-6411', 'title': 'Medical Information Call Center', 'organization': 'Otonomy'}, 'certainAgreement': {'otherDetails': 'Publication subject to Sponsor consent.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported during dosing and up to 1 month following dosing.', 'eventGroups': [{'id': 'EG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 5, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 10, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Otoscopic Examination: Tympanic Membrane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration'}, {'id': 'OG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 month', 'description': 'Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who received study drug.'}, {'type': 'PRIMARY', 'title': 'Otoscopic Examination: Middle Ear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration'}, {'id': 'OG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 month', 'description': 'Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects that received drug'}, {'type': 'PRIMARY', 'title': 'Feasibility of Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration'}, {'id': 'OG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day1', 'description': 'Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who receieved study drug'}, {'type': 'PRIMARY', 'title': 'Overall Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 ciprofloxacin: single administration'}, {'id': 'OG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Number of subjects with at least 1 adverse event', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'Number of subjects with no adverse events', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 month', 'description': 'Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects that received study drug'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 ciprofloxacin: single administration'}, {'id': 'OG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (two weeks from dosing)', 'description': 'Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:\n\nNone = 0 Mild = 1 Moderate = 2 Severe = 3', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis set: All subjects who were randomized and were used for assessments of clinical activity'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'OG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration'}, {'id': 'OG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (2 weeks from dosing)', 'description': 'Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:\n\nNone = 0 Mild = 1 Moderate = 2 Severe = 3', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol Analysis Set defined as all subjects in the ITT analysis set who received study drug, completed Visit 4 (Day 15), and did not have a major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'FG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration'}, {'id': 'FG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}, {'id': 'BG001', 'title': '12 mg OTO-201', 'description': '12 mg ciprofloxacin: single administration'}, {'id': 'BG002', 'title': '24 mg OTO-201', 'description': '24 mg ciprofloxacin: single administration'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '21.95', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '20.12', 'groupId': 'BG001'}, {'value': '43.0', 'spread': '23.74', 'groupId': 'BG002'}, {'value': '37.3', 'spread': '22.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2015-07-28', 'resultsFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Otoscopic Examination: Tympanic Membrane', 'timeFrame': 'Up to 1 month', 'description': 'Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)'}, {'measure': 'Otoscopic Examination: Middle Ear', 'timeFrame': 'Up to 1 month', 'description': 'Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)'}, {'measure': 'Feasibility of Administration', 'timeFrame': 'Day1', 'description': 'Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".'}, {'measure': 'Overall Adverse Events', 'timeFrame': 'up to 1 month', 'description': 'Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)', 'timeFrame': 'Day 15 (two weeks from dosing)', 'description': 'Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:\n\nNone = 0 Mild = 1 Moderate = 2 Severe = 3'}, {'measure': 'Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)', 'timeFrame': 'Day 15 (2 weeks from dosing)', 'description': 'Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:\n\nNone = 0 Mild = 1 Moderate = 2 Severe = 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Otitis externa', "Swimmer's ear", 'Ear infection'], 'conditions': ['Otitis Externa']}, 'descriptionModule': {'briefSummary': 'This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria includes, but is not limited to:\n\n* Subject is a male or female aged 6 months to 80 years, inclusive\n* Subject has a clinical diagnosis of unilateral otitis externa\n* Subject or subject's caregiver is willing to comply with the protocol and attend all study visits\n\nExclusion Criteria includes, but is not limited to:\n\n* Subject has tympanic membrane perforation\n* Subject has a history of known immunodeficiency disease\n* Subject has fungal otitis externa, based on clinical signs"}, 'identificationModule': {'nctId': 'NCT02511561', 'briefTitle': 'OTO-201 for the Treatment of Otitis Externa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otonomy, Inc.'}, 'officialTitle': 'A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa', 'orgStudyIdInfo': {'id': '201-201506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.1 mL OTO-201', 'description': 'Ciprofloxacin', 'interventionNames': ['Drug: OTO-201 (ciprofloxacin)']}, {'type': 'EXPERIMENTAL', 'label': '0.2 mL OTO-201', 'description': 'Ciprofloxacin', 'interventionNames': ['Drug: OTO-201 (ciprofloxacin)']}, {'type': 'EXPERIMENTAL', 'label': '0.4 mL OTO-201', 'description': 'Ciprofloxacin', 'interventionNames': ['Drug: OTO-201 (ciprofloxacin)']}], 'interventions': [{'name': 'OTO-201 (ciprofloxacin)', 'type': 'DRUG', 'armGroupLabels': ['0.1 mL OTO-201', '0.2 mL OTO-201', '0.4 mL OTO-201']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Email Otonomy Central Contact for Trial Locations', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Carl LeBel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Otonomy, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otonomy, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}