Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01230593
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2010-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chalazion Conservative Treatment Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009824', 'term': 'Ointments'}, {'id': 'D014031', 'term': 'Tobramycin'}, {'id': 'D000078162', 'term': 'Tobramycin, Dexamethasone Drug Combination'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D004338', 'term': 'Drug Combinations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'albert.wu@mssm.edu', 'phone': '2125184524', 'title': 'Albert Wu MD PhD', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Large loss to follow-up - only 70% completed follow-up - was a limitation.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored over a time frame of 4-6 weeks from baseline enrollment of each participant. Participants returned for follow-up between 4 and 6 weeks after starting treatment.', 'description': 'Serious Adverse Events', 'eventGroups': [{'id': 'EG000', 'title': 'Hot Compress', 'description': 'Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.\n\nHot Compresses: Hot compresses 3x/day to eyelids', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hot Compress, Tobrex Drops, Tobrex Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Hot Compress, Tobradex Drops, Tobradex Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hot Compress', 'description': 'Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.\n\nHot Compresses: Hot compresses 3x/day to eyelids'}, {'id': 'OG001', 'title': 'Hot Compress + Tobramycin Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.'}, {'id': 'OG002', 'title': 'Hot Compress + Tobramycin/Dexamethasone Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-6 weeks', 'description': 'Defined as number of patients with chalazion size regression of 100%', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Chalazion Size Difference Post-Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Hot Compress', 'description': 'Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.\n\nHot Compresses: Hot compresses 3x/day to eyelids'}, {'id': 'OG001', 'title': 'Hot Compress + Tobramycin Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.'}, {'id': 'OG002', 'title': 'Hot Compress + Tobramycin/Dexamethasone Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '3', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '3', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hot Compress', 'description': 'Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.\n\nHot Compresses: Hot compresses 3x/day to eyelids'}, {'id': 'FG001', 'title': 'Hot Compress + Tobramycin Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.'}, {'id': 'FG002', 'title': 'Hot Compress + Tobramycin/Dexamethasone Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Hot Compress', 'description': 'Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.\n\nHot Compresses: Hot compresses 3x/day to eyelids'}, {'id': 'BG001', 'title': 'Hot Compress + Tobramycin Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.'}, {'id': 'BG002', 'title': 'Hot Compress + Tobramycin/Dexamethasone Drops and Ointment', 'description': 'In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.\n\nTobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.50', 'spread': '15', 'groupId': 'BG000'}, {'value': '46.42', 'spread': '19', 'groupId': 'BG001'}, {'value': '47.52', 'spread': '17', 'groupId': 'BG002'}, {'value': '47.41', 'spread': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pre-treatment lesion duration (months)', 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '6', 'groupId': 'BG000'}, {'value': '2.88', 'spread': '3', 'groupId': 'BG001'}, {'value': '5.72', 'spread': '13', 'groupId': 'BG002'}, {'value': '3.96', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Initial lesion size (mm)', 'classes': [{'categories': [{'measurements': [{'value': '6.05', 'spread': '3', 'groupId': 'BG000'}, {'value': '6.16', 'spread': '3', 'groupId': 'BG001'}, {'value': '6.38', 'spread': '3', 'groupId': 'BG002'}, {'value': '6.19', 'spread': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-09', 'studyFirstSubmitDate': '2010-10-27', 'resultsFirstSubmitDate': '2017-04-04', 'studyFirstSubmitQcDate': '2010-10-28', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-09', 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Resolution', 'timeFrame': '4-6 weeks', 'description': 'Defined as number of patients with chalazion size regression of 100%'}], 'secondaryOutcomes': [{'measure': 'Chalazion Size Difference Post-Treatment', 'timeFrame': 'baseline and 4-6 weeks', 'description': 'Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chalazion Unspecified Eye, Unspecified Eyelid', 'Chalazion Left Eye, Unspecified Eyelid', 'Chalazion Right Eye, Unspecified Eyelid', 'Chalazion Both Eyes']}, 'referencesModule': {'references': [{'pmid': '29338124', 'type': 'DERIVED', 'citation': 'Wu AY, Gervasio KA, Gergoudis KN, Wei C, Oestreicher JH, Harvey JT. Conservative therapy for chalazia: is it really effective? Acta Ophthalmol. 2018 Jun;96(4):e503-e509. doi: 10.1111/aos.13675. Epub 2018 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'An eyelid stye, or chalazion, is the most common eyelid ailment, and is caused by the blockage of one of the oil secreting glands of the eyelid (meibomian glands). This leads to a typically painful, swollen, and red eyelid bump that lasts from days to weeks and months. The chalazion may cause tearing, pressure on the cornea, and irritation, all of which contribute to its morbidity. There are many anecdotal first line treatments for this condition, including warm compresses to the eyelid, topical antibiotics, topical steroids, topical combination antibiotic/steroid, and oral antibiotics. There have been no clinical trials to compare the efficacy of any of these conservative treatments. We wish to determine the most effective conservative medical treatment for chalazia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients age 18 and above\n* Patient with a palpable chalazion on any eyelid\n* Patients with multiple chalazia but only a single one on each lid\n* Normal lid anatomy enabling lid eversion\n\nExclusion Criteria\n\n* Patients with chalazia with atypical features (recurring chalazion, abnormal surrounding lid tissue, associated loss of lashes) that may indicate suspicion of malignancy\n* Patients allergic to any agents being used in the study (tobramycin, dexamethasone)\n* Patients who have had previous eyelid surgery to the same eyelid as the chalazion\n* Patients under 18 years of age\n* Patients without palpable lid chalazion\n* Patients with multiple chalazia on one eyelid\n* Patients with concurrent eyelid infection (cellulitis or conjunctivitis)\n* Patients unable to give consent'}, 'identificationModule': {'nctId': 'NCT01230593', 'briefTitle': 'Chalazion Conservative Treatment Trial', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments', 'orgStudyIdInfo': {'id': '10-469'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hot Compress', 'description': '"Hot Compress"', 'interventionNames': ['Other: Hot Compresses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobrex', 'description': '"Hot Compress", "Tobrex Drops", "Tobrex Ointment"', 'interventionNames': ['Drug: Hot Compress plus Tobramycin Drops and Ointment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobradex', 'description': '"Hot Compress", "Tobradex Drops", "Tobradex Ointment"', 'interventionNames': ['Drug: Hot compress plus Tobramycin/Dexamethasone Drops and Ointment']}], 'interventions': [{'name': 'Hot Compress plus Tobramycin Drops and Ointment', 'type': 'DRUG', 'otherNames': ['Aktob', 'Tobralcon', 'Tobrasol', 'Tobramycin'], 'description': 'In addition to hot compress, Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.', 'armGroupLabels': ['Tobrex']}, {'name': 'Hot compress plus Tobramycin/Dexamethasone Drops and Ointment', 'type': 'DRUG', 'otherNames': ['Tobramycin/dexamethasone'], 'description': 'In addition to hot compress, Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.', 'armGroupLabels': ['Tobradex']}, {'name': 'Hot Compresses', 'type': 'OTHER', 'description': 'Hot compresses 3x/day to eyelids', 'armGroupLabels': ['Hot Compress']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11373', 'city': 'Elmhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Elmhurst Hospital Center', 'geoPoint': {'lat': 40.73649, 'lon': -73.87791}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'L8G 5E4', 'city': 'Stoney Creek', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital Eye Clinic", 'geoPoint': {'lat': 43.21681, 'lon': -79.76633}}], 'overallOfficials': [{'name': 'Albert Y Wu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, {'name': 'Edward-Elmhurst Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Ph.D.', 'investigatorFullName': 'Albert Wu', 'investigatorAffiliation': 'McMaster University'}}}}