Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT03787212
Status:
TERMINATED
Last Update Posted:
2020-02-05
First Post:
2018-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MiBo ThermoFlo Lid Temperature Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CColesb@its.jnj.com', 'phone': '904 443 3449', 'title': 'Chantal Coles-Brennan, OD - Principal Research Optometrist', 'organization': 'Johnson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was discontinued by the sponsor, due to the manufacturer of the MiBo ThermoFlo receiving a warning letter from the FDA regarding non-compliance to 21 CFR part 820. Subsequently, the primary analyses were not carried.'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the entire duration of the study. Approximately 1 day per subject, due to early study Termination.', 'eventGroups': [{'id': 'EG000', 'title': 'Test', 'description': 'Subjects that recieved the Test treatment during any point in this study', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects that recieved the Control treatment at any point during the study.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Posterior Eyelid Temperature (Palpebral Conjunctiva)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test', 'description': 'Subjects that recieved the Test treatment during any point in this study'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects that recieved the Control treatment at any point during this study.'}], 'classes': [{'title': 'Left Eye - Lower Lid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.835', 'spread': '0.9829', 'groupId': 'OG000'}]}]}, {'title': 'Left Eye - Upper Lid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.545', 'spread': '0.1485', 'groupId': 'OG000'}]}]}, {'title': 'Right Eye - Lower Lid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.42', 'spread': '0', 'groupId': 'OG000'}, {'value': '37.415', 'spread': '0.5162', 'groupId': 'OG001'}]}]}, {'title': 'Right Eye - Upper Lid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.77', 'spread': '0', 'groupId': 'OG000'}, {'value': '37.19', 'spread': '0.1131', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-minutes post treatment', 'description': 'Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of \\>40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.', 'unitOfMeasure': 'Celcius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test/Control', 'description': 'Subjects randomized to this sequence received the MiBo ThermoFlo as Test in their left eye and then received the Bruder Moist Heat Single Eye Compress as Control in their right eye.'}, {'id': 'FG001', 'title': 'Control/Test', 'description': 'Subjects randomized to this sequence received the Bruder Moist Heat Single Eye Compress as Control in their left eye and then received the MiBo ThermoFlo as Test in their right eye'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 4 subjects were enrolled into this study prior to its termination. This study was terminated early by the sponsor due to a warning letter from the FDA regarding non-compliance to 21 CFR part 820.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Subjects', 'description': 'All subjects enrolled into the study prior to early study termination.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.25', 'spread': '7.847', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Count of Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-15', 'size': 5830563, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-17T11:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Study terminated due to safety assessment of the study product', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2018-12-24', 'resultsFirstSubmitDate': '2020-01-17', 'studyFirstSubmitQcDate': '2018-12-24', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-17', 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posterior Eyelid Temperature (Palpebral Conjunctiva)', 'timeFrame': '12-minutes post treatment', 'description': 'Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of \\>40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, contralateral, single-site, single-visit unmasked evaluation of external and internal eyelid temperature after treatment with the MiBo ThermoFlo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Potential subjects must satisfy all the following criteria to be enrolled in the study:\n\n 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.\n 3. Between 18 and 80 (inclusive) years of age at the time of screening.\n 4. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).\n\n Exclusion Criteria:\n* Potential subjects who meet any of the following criteria will be excluded from participating in the study:\n\n 1. Currently pregnant or breastfeeding.\n 2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with participation in the study.\n 3. Clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection).\n 4. Grade 3-4 Percentage of Partial Meibomian Glands on the Pult 5-point grading scale.\n 5. Any active Ocular Infection or Inflammation\n 6. Any history of eyelid surgery or abnormality\n 7. History of Metal Implants in the Eyelids\n 8. Any known hypersensitivity or allergic reaction to ultrasound coupling gel.\n 9. LASIK Surgery within 2 weeks of the Baseline Visit.\n 10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.\n 11. History of MiBo ThermoFlo or Lipiflow treatment Within the Last 6 months.\n 12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)."}, 'identificationModule': {'nctId': 'NCT03787212', 'briefTitle': 'MiBo ThermoFlo Lid Temperature Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'MiBo ThermoFlo Lid Temperature Evaluation', 'orgStudyIdInfo': {'id': 'CR-6281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MiBo ThermoFlo / Bruder mask', 'description': 'Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.', 'interventionNames': ['Device: MiBo ThermoFlo', 'Device: Bruder Mask']}, {'type': 'EXPERIMENTAL', 'label': 'Bruder Mask / MiBo ThermoFlo', 'description': 'Subjects between the ages of 18 to 80 years will be randomly assigned to 1 of 2 treatment sequences in a contralateral fashion.', 'interventionNames': ['Device: MiBo ThermoFlo', 'Device: Bruder Mask']}], 'interventions': [{'name': 'MiBo ThermoFlo', 'type': 'DEVICE', 'description': 'Test Device', 'armGroupLabels': ['Bruder Mask / MiBo ThermoFlo', 'MiBo ThermoFlo / Bruder mask']}, {'name': 'Bruder Mask', 'type': 'DEVICE', 'description': 'Control Device', 'armGroupLabels': ['Bruder Mask / MiBo ThermoFlo', 'MiBo ThermoFlo / Bruder mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston, College of Optometry', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}