Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT03779503
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-12-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Daily Disposable Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'javega@coopervision.com', 'phone': '9256213761', 'title': 'Jose A. Vega, O.D, MSc., FAAO', 'organization': 'CooperVision. Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From dispense up to one week for each study lenses, a total of two weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Fit - Horizontal Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely nasal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Temporal', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Temporal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Horizontal Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely nasal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly nasal', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Temporal', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Temporal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Week', 'description': 'Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)', 'unitOfMeasure': 'participants of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Vertical Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely inferior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inferior', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Superior', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Superior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Vertical Centration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely inferior', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inferior', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Slightly Superior', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Extremely Superior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Week', 'description': 'Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely inadequate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inadequate', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Slightly excessive', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Extremely excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Corneal Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely inadequate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inadequate', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Slightly excessive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Extremely excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Week', 'description': 'Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Lens Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely inadequate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inadequate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Slightly excessive', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Extremely excessive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Fit - Lens Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'title': 'Extremely inadequate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Slightly inadequate', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Optimum', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Slightly excessive', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Extremely excessive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Week', 'description': 'Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Score for Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '93.1', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '95.0', 'spread': '8.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Score for Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens'}, {'id': 'OG001', 'title': 'Somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '91.7', 'spread': '12.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week', 'description': 'Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Midafilcon A Then Somofilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear the cross-over to somofilcon A for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens'}, {'id': 'FG001', 'title': 'Somofilcon A Then Midafilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear then cross-over to midafilcon A for one week of daily wear during the study.\n\nsomofilcon A: somofilcon A 1 day daily disposable contact lens midafilcon A: midafilcon A 1 day daily disposable contact lens'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Subjects were randomized to wear either midafilcon A 1 day or somofilcon A 1 day for one week of daily wear the cross-over to the other for one week of daily wear during the study.\n\nmidafilcon A: midafilcon A 1 day daily disposable contact lens somofilcon A: somofilcon A 1 day daily disposable contact lens'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-25', 'size': 2465335, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-14T14:00', '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': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2018-12-13', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2018-12-17', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-14', 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Fit - Horizontal Centration', 'timeFrame': 'Baseline', 'description': 'Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)'}, {'measure': 'Lens Fit - Horizontal Centration', 'timeFrame': 'One Week', 'description': 'Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)'}, {'measure': 'Lens Fit - Vertical Centration', 'timeFrame': 'Baseline', 'description': 'Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)'}, {'measure': 'Lens Fit - Vertical Centration', 'timeFrame': 'One Week', 'description': 'Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)'}, {'measure': 'Lens Fit - Corneal Coverage', 'timeFrame': 'Baseline', 'description': 'Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)'}, {'measure': 'Lens Fit - Corneal Coverage', 'timeFrame': 'One Week', 'description': 'Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)'}, {'measure': 'Lens Fit - Lens Movement', 'timeFrame': 'Baseline', 'description': 'Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)'}, {'measure': 'Lens Fit - Lens Movement', 'timeFrame': 'One Week', 'description': 'Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)'}], 'secondaryOutcomes': [{'measure': 'Subjective Score for Vision', 'timeFrame': 'Baseline', 'description': 'Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)'}, {'measure': 'Subjective Score for Vision', 'timeFrame': 'One week', 'description': 'Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism Bilateral']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.', 'detailedDescription': 'This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. They are between 18 and 40 years of age (inclusive).\n2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.\n3. They are willing and able to follow the protocol.\n4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.\n5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.\n6. They own a wearable pair of spectacles and wear them on the day of the initial visit.\n7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.\n8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).\n9. They agree not to participate in other clinical research for the duration of the study.\n\nExclusion Criteria:\n\n1. They have an ocular disorder, which would normally contra-indicate contact lens wear.\n2. They have a systemic disorder, which would normally contra-indicate contact lens wear.\n3. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.\n4. They are aphakic.\n5. They have had corneal refractive surgery.\n6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.\n7. They are pregnant or breastfeeding.\n8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear\n9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.\n10. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.'}, 'identificationModule': {'nctId': 'NCT03779503', 'briefTitle': 'Comparison of Two Daily Disposable Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Clinical Comparison of Two Daily Disposable Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-99 (C18-649)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'midafilcon A', 'description': 'Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.', 'interventionNames': ['Device: midafilcon A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'somofilcon A', 'description': 'Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.', 'interventionNames': ['Device: somofilcon A']}], 'interventions': [{'name': 'midafilcon A', 'type': 'DEVICE', 'description': 'midafilcon A 1 day daily disposable contact lens', 'armGroupLabels': ['midafilcon A']}, {'name': 'somofilcon A', 'type': 'DEVICE', 'description': 'somofilcon A 1 day daily disposable contact lens', 'armGroupLabels': ['somofilcon A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94588', 'city': 'Pleasanton', 'state': 'California', 'country': 'United States', 'facility': 'CooperVision Inc.', 'geoPoint': {'lat': 37.66243, 'lon': -121.87468}}], 'overallOfficials': [{'name': 'Philip Morgan, PhD MCOptom FAAO FBCLA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurolens Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}