Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT00705159
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2008-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069559', 'term': 'Loteprednol Etabonate'}, {'id': 'D014031', 'term': 'Tobramycin'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009328', 'term': 'Nebramycin'}, {'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tuyen.ong@bausch.com', 'phone': '(973) 360-6389', 'title': 'Tuyen Ong, MD, MRCOphth', 'organization': 'Bausch & Lomb Incorporated'}, 'certainAgreement': {'otherDetails': 'All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 days', 'description': 'Safety population', 'eventGroups': [{'id': 'EG000', 'title': 'Loteprednol Etabonate and Tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).', 'otherNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Loteprednol Etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).', 'otherNumAtRisk': 35, 'otherNumAffected': 2, 'seriousNumAtRisk': 35, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Tobramycin', 'description': 'Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).', 'otherNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Vehicle', 'description': 'Vehicle of Zylet. One or two drops in study eye four times a day (QID).', 'otherNumAtRisk': 33, 'otherNumAffected': 2, 'seriousNumAtRisk': 33, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'notes': 'Non-ocular AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra'}], 'seriousEvents': [{'term': 'Respiratory distress', 'notes': 'Severe respiratory distress with moderate otitis media, unrelated to study drug or participation but due to concurrent illness.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchiolitis', 'notes': 'Bronchiolitis and dehydration unrelated to study drug or participation but due to concurrent illness.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Total Blepharoconjunctivitis Grade.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate and Tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).'}, {'id': 'OG002', 'title': 'Tobramycin', 'description': 'Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of Zylet. One or two drops in study eye four times a day (QID).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.41', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '-11.23', 'spread': '3.98', 'groupId': 'OG001'}, {'value': '-10.68', 'spread': '4.71', 'groupId': 'OG002'}, {'value': '-10.30', 'spread': '5.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 15 days', 'description': 'Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study eye, ITT Population, Non-missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate and Tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).'}, {'id': 'OG002', 'title': 'Tobramycin', 'description': 'Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of Zylet. One or two drops in study eye four times a day (QID).'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.32', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '-7.74', 'spread': '3.90', 'groupId': 'OG001'}, {'value': '-5.94', 'spread': '4.00', 'groupId': 'OG002'}, {'value': '-6.58', 'spread': '3.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 3', 'description': 'Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study eye, ITT population, non-missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Loteprednol Etabonate and Tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).'}, {'id': 'OG001', 'title': 'Loteprednol Etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).'}, {'id': 'OG002', 'title': 'Tobramycin', 'description': 'Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'Vehicle of Zylet. One or two drops in study eye four times a day (QID).'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.03', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '-10.94', 'spread': '4.69', 'groupId': 'OG001'}, {'value': '-9.90', 'spread': '3.80', 'groupId': 'OG002'}, {'value': '-10.03', 'spread': '4.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7', 'description': 'Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study eye ITT population, subjects with non-missing data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Loteprednol Etabonate and Tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).'}, {'id': 'FG001', 'title': 'Loteprednol Etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).'}, {'id': 'FG002', 'title': 'Tobramycin', 'description': 'Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).'}, {'id': 'FG003', 'title': 'Vehicle', 'description': 'Vehicle of Zylet. One or two drops in study eye four times a day (QID).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 17 sites in the United States. First participant was enrolled on 6/26/2008 and last participant visit was 3/24/2010.', 'preAssignmentDetails': 'A total of 137 pediatric subjects, 0 to 6 years of age, of either gender and any race, who had a clinical diagnosis of blepharoconjunctivitis in at least one eye were randomized in this study. 126 Participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Loteprednol Etabonate and Tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).'}, {'id': 'BG001', 'title': 'Loteprednol Etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate 0.5%). One or two drops in study eye four times a day (QID).'}, {'id': 'BG002', 'title': 'Tobramycin', 'description': 'Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).'}, {'id': 'BG003', 'title': 'Vehicle', 'description': 'Vehicle of Zylet. One or two drops in study eye four times a day (QID).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0-6 years', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2008-06-20', 'resultsFirstSubmitDate': '2011-06-14', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-15', 'studyFirstPostDateStruct': {'date': '2008-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Total Blepharoconjunctivitis Grade.', 'timeFrame': 'Baseline to 15 days', 'description': 'Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2', 'timeFrame': 'Baseline to Day 3', 'description': 'Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.'}, {'measure': 'Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3', 'timeFrame': 'Baseline to Day 7', 'description': 'Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blepharokeratoconjunctivitis'], 'conditions': ['Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Week', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* children 0-6 years of age.\n* clinical diagnosis of blepharoconjunctivitis\n* Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.\n* Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.\n\nExclusion Criteria:\n\n* Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.\n* Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.\n* Subjects who are monocular.\n* Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.\n* Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study."}, 'identificationModule': {'nctId': 'NCT00705159', 'briefTitle': 'Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis', 'orgStudyIdInfo': {'id': '550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loteprednol etabonate and tobramycin', 'description': 'Drug: Zylet (loteprednol etabonate and tobramycin)', 'interventionNames': ['Drug: loteprednol etabonate and tobramycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Loteprednol etabonate', 'description': 'Drug: Lotemax (loteprednol etabonate)', 'interventionNames': ['Drug: loteprednol etabonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tobramycin', 'description': 'Drug: Tobramycin', 'interventionNames': ['Drug: Tobramycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle of Zylet', 'interventionNames': ['Drug: Vehicle of Zylet']}], 'interventions': [{'name': 'loteprednol etabonate and tobramycin', 'type': 'DRUG', 'otherNames': ['Zylet'], 'description': 'Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.', 'armGroupLabels': ['Loteprednol etabonate and tobramycin']}, {'name': 'loteprednol etabonate', 'type': 'DRUG', 'otherNames': ['Lotemax'], 'description': 'Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.', 'armGroupLabels': ['Loteprednol etabonate']}, {'name': 'Tobramycin', 'type': 'DRUG', 'description': 'Topical ocular administration of Tobramycin QID for 14 days.', 'armGroupLabels': ['Tobramycin']}, {'name': 'Vehicle of Zylet', 'type': 'DRUG', 'description': 'Topical ocular administration of the vehicle of Zylet QID for 14 days.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16501', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pediatric Ophthalmology of Erie', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}