Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-30 @ 7:51 PM
Study NCT ID:
NCT05805059
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2023-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jvega2@coopervision.com', 'phone': '925-621-3761', 'title': 'Jose A. Vega,OD,MSc,FAAO, PhD', 'organization': 'Coopervision'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study, approximately 2 weeks.', 'description': '\\[Not Specified\\]', 'eventGroups': [{'id': 'EG000', 'title': 'Control Contact Lens', 'description': 'Participants that received Control Lens during either the first or second period of the study.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 1, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test Contact Lens', 'description': 'Participants that received Test Lens during either the first or second period of the study.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 1, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'eye twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Handling on Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Contact Lens', 'description': 'Participants that received Control Lens during either the first or second period of the study'}, {'id': 'OG001', 'title': 'Test Contact Lens', 'description': 'Participants that received Test Lens during either the first or second period of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'spread': '12', 'groupId': 'OG000'}, {'value': '94', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected once on day 6 at the end of wear', 'description': 'Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Contact Lens, Then Test Contact Lens', 'description': 'Participants wore Control Lens for 1 week (Period 1), and then Test Lens for 1 week (Period 2).'}, {'id': 'FG001', 'title': 'Test Contact Lens, Then Control Contact Lens', 'description': 'Participants wore Test Lens for 1 week (Period 1), and then Control Lens for 1 week (Period 2).'}], 'periods': [{'title': 'Period 1 (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Analysis Population', 'description': 'All participants who completed study. (Total study population n=68)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '4.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', '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.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-23', 'size': 2159320, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-02T16:09', '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': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-20', 'studyFirstSubmitDate': '2023-03-28', 'resultsFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-20', 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Handling on Removal', 'timeFrame': 'Collected once on day 6 at the end of wear', 'description': 'Lens Handling on Removal, using a 0-100 scale (0=Very difficult, 100=Very easy)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the performance of two daily disposable silicone hydrogel contact lenses.', 'detailedDescription': 'This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover, daily wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer;\n2. Has read and signed an information consent letter;\n3. Self-reports having a full eye examination in the previous two years;\n4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;\n5. Is willing and able to follow instructions and maintain the appointment schedule;\n6. Habitually wears soft contact lenses, for the past 3 months minimum;\n\n 1. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay Energys\n 2. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS MAX 1-Day or ACUVUE® OASYS 1-Day.\n7. Has refractive astigmatism no higher than -0.75DC in each eye;\n8. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).\n\nExclusion Criteria:\n\n1. Is participating in any concurrent clinical or research study;\n2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;\n3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;\n4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;\n5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;\n6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;\n7. Has undergone refractive error surgery or intraocular surgery.'}, 'identificationModule': {'nctId': 'NCT05805059', 'briefTitle': 'Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Contact Lens, Then Test Contact Lens', 'description': 'Participants will wear control contact lenses for one week and then crossover to test contact lenses for one week.', 'interventionNames': ['Device: Control Contact Lens (stenfilcon A)', 'Device: Test Contact Lens (senofilcon A)']}, {'type': 'EXPERIMENTAL', 'label': 'Test Contact Lens, Then Control Contact Lens', 'description': 'Participants will wear test contact lenses for one week and then crossover to control contact lenses for one week.', 'interventionNames': ['Device: Control Contact Lens (stenfilcon A)', 'Device: Test Contact Lens (senofilcon A)']}], 'interventions': [{'name': 'Control Contact Lens (stenfilcon A)', 'type': 'DEVICE', 'description': 'one week wear', 'armGroupLabels': ['Control Contact Lens, Then Test Contact Lens', 'Test Contact Lens, Then Control Contact Lens']}, {'name': 'Test Contact Lens (senofilcon A)', 'type': 'DEVICE', 'description': 'one week of wear', 'armGroupLabels': ['Control Contact Lens, Then Test Contact Lens', 'Test Contact Lens, Then Control Contact Lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Coan Eye Care', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Sacco Eye Group, PLLC', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProCare Vision Center', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': 'N2L 3S1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Insight Eye Care', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Andrew Sacco', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sacco Eye Group, PLLC'}, {'name': 'Carolyn MacNeil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insight Eye Care'}, {'name': 'Katherine Bickle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ProCare Vision Center'}, {'name': 'Roxanne Achong-Coan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coan Eye Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre for Ocular Research & Education, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}