Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-26 @ 12:15 AM
Study NCT ID:
NCT03762668
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2018-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance Assessment of a Modified Daily Disposable Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. CDMA Project Lead, Vision Care', 'organization': 'Alcon Research, LLC'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events were collected (observed or reported) for the duration of the individual's participation in the study, approximately 2 weeks.", 'description': 'An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study lenses. This analysis population includes all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).', 'eventGroups': [{'id': 'EG000', 'title': 'MDACL', 'description': 'MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DACL', 'description': 'DACL worn for approximately 1 week, Period 1 or Period 2, as randomized', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'High Contrast Distance Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDACL', 'description': 'MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized'}, {'id': 'OG001', 'title': 'DACL', 'description': 'DACL worn for approximately 1 week, Period 1 or Period 2, as randomized'}], 'classes': [{'title': 'Day 1 Dispense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 7 Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.005', 'estimateComment': 'test minus control', 'statisticalMethod': 'mixed effects repeated measures model', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Dispense, Day 7 Follow-Up', 'description': 'Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.', 'unitOfMeasure': 'logMar', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MDACL, Then DACL', 'description': 'Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.'}, {'id': 'FG001', 'title': 'DACL, Then MDACL', 'description': 'DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.'}], 'periods': [{'title': 'Period 1, First Week of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2, Second Week of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 5 investigative sites located in the United States.', 'preAssignmentDetails': 'Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MDACL, Then DACL', 'description': 'MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.'}, {'id': 'BG001', 'title': 'DACL, Then MDACL', 'description': 'DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '31.7', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 989651, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-17T17:27', 'hasProtocol': False}, {'date': '2018-11-07', 'size': 1202830, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-17T17:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2018-12-01', 'resultsFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2018-12-01', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-19', 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Contrast Distance Visual Acuity (logMAR)', 'timeFrame': 'Day 1 Dispense, Day 7 Follow-Up', 'description': 'Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lens', 'Vision correction', 'Visual acuity'], 'conditions': ['Refractive Errors', 'Myopia', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare visual acuity between two daily disposable contact lenses.', 'detailedDescription': 'The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and sign an approved Informed Consent form;\n* Current wearer of commercial DAILIES TOTAL1 Contact Lenses in both eyes;\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any eye condition that contraindicates contact lens wear, as determined by the Investigator;\n* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator;\n* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week)\n* Monocular (only one eye with functional vision);\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03762668', 'briefTitle': 'Performance Assessment of a Modified Daily Disposable Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Performance Assessment of a Modified Daily Disposable Contact Lens', 'orgStudyIdInfo': {'id': 'CLP691-C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MDACL, then DACL', 'description': 'Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.', 'interventionNames': ['Device: Modified delefilcon A contact lenses', 'Device: Delefilcon A contact lenses']}, {'type': 'OTHER', 'label': 'DACL, then MDACL', 'description': 'DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.', 'interventionNames': ['Device: Modified delefilcon A contact lenses', 'Device: Delefilcon A contact lenses']}], 'interventions': [{'name': 'Modified delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['MDACL'], 'description': 'Spherical soft daily disposable contact lens', 'armGroupLabels': ['DACL, then MDACL', 'MDACL, then DACL']}, {'name': 'Delefilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DACL'], 'description': 'Spherical soft daily disposable contact lens', 'armGroupLabels': ['DACL, then MDACL', 'MDACL, then DACL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33405', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Sr. CDMA Project Lead, Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}