Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT03349632
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Comparison of 4 Daily Disposable Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Senior Clinical Project Lead, GCRA - Vision Care', 'organization': 'Alcon, A Novartis Division'}, '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': 'Dispense through study completion, an average of 2 weeks', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.', 'eventGroups': [{'id': 'EG000', 'title': 'DD T2 (Sequence 1 and 2)', 'description': 'Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oasys 1- Day (Sequence 1 and 2)', 'description': 'Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DD T2 (Sequence 3 and 4)', 'description': 'Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MyDay (Sequence 3 and 4)', 'description': 'Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'DD T2 (Sequence 5 and 6)', 'description': 'Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Moist (Sequence 5 and 6)', 'description': 'Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Quality of Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DD T2 (Sequence 1 and 2)', 'description': 'Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week'}, {'id': 'OG001', 'title': 'Oasys 1-Day (Sequence 1 and 2)', 'description': 'Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week'}, {'id': 'OG002', 'title': 'DD T2 (Sequence 3 and 4)', 'description': 'Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week'}, {'id': 'OG003', 'title': 'MyDay (Sequence 3 and 4)', 'description': 'Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week'}, {'id': 'OG004', 'title': 'DD T2 (Sequence 5 and 6)', 'description': 'Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week'}, {'id': 'OG005', 'title': 'Moist (Sequence 5 and 6)', 'description': 'Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '9.4', 'spread': '0.8', 'groupId': 'OG003'}, {'value': '9.2', 'spread': '1.1', 'groupId': 'OG004'}, {'value': '8.8', 'spread': '1.7', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8, each product', 'description': 'Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DD T2/Oasys 1-Day (Sequence 1)', 'description': 'Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized'}, {'id': 'FG001', 'title': 'Oasys 1-Day/DD T2 (Sequence 2)', 'description': 'Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized'}, {'id': 'FG002', 'title': 'DD T2/MyDay (Sequence 3)', 'description': 'Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized'}, {'id': 'FG003', 'title': 'MyDay/DD T2 (Sequence 4)', 'description': 'Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized'}, {'id': 'FG004', 'title': 'DD T2/Moist (Sequence 5)', 'description': 'Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized'}, {'id': 'FG005', 'title': 'Moist/DD T2 (Sequence 6)', 'description': 'Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized'}], 'periods': [{'title': 'Period 1, First Week of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Second Week of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 3 investigational sites located in the United States.', 'preAssignmentDetails': 'Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-02', 'size': 3948043, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-18T15:22', 'hasProtocol': True}, {'date': '2017-11-17', 'size': 1554596, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-18T15:22', 'hasProtocol': False}]}}, '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': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2017-11-17', 'resultsFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-30', 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Quality of Vision', 'timeFrame': 'Day 8, each product', 'description': 'Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lenses', 'Myopia', 'Near-sighted', 'Daily disposable'], 'conditions': ['Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.', 'detailedDescription': 'The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and must sign an approved Informed Consent Form\n* Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months\n* Best Corrected Visual Acuity of 20/25 Snellen or better in each eye\n* Willing to stop wearing habitual contact lenses for the duration of study participation\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator.\n* Routinely sleeps in habitual contact lenses\n* Currently wears Oasys 1-Day, MyDay, or Moist contact lenses\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03349632', 'briefTitle': 'Clinical Comparison of 4 Daily Disposable Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Comparison of 4 Daily Disposable Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'CLE383-C004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DD T2/Oasys 1-Day', 'description': 'Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized', 'interventionNames': ['Device: verofilcon A contact lenses', 'Device: senofilcon A contact lenses']}, {'type': 'OTHER', 'label': 'DD T2/MyDay', 'description': 'Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized', 'interventionNames': ['Device: verofilcon A contact lenses', 'Device: stenfilcon A contact lenses']}, {'type': 'OTHER', 'label': 'DD T2/Moist', 'description': 'Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized', 'interventionNames': ['Device: verofilcon A contact lenses', 'Device: etafilcon A contact lenses']}], 'interventions': [{'name': 'verofilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['DDT2'], 'description': 'Investigational spherical silicone hydrogel contact lenses for daily disposable wear', 'armGroupLabels': ['DD T2/Moist', 'DD T2/MyDay', 'DD T2/Oasys 1-Day']}, {'name': 'senofilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['ACUVUE OASYS® 1-Day with HydraLuxe™ Technology', 'Oasys 1-Day'], 'description': 'Commercially available spherical silicone hydrogel contact lenses for daily disposable wear', 'armGroupLabels': ['DD T2/Oasys 1-Day']}, {'name': 'stenfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['MyDay®', 'MyDay'], 'description': 'Commercially available spherical silicone hydrogel contact lenses for daily disposable wear', 'armGroupLabels': ['DD T2/MyDay']}, {'name': 'etafilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['1-Day ACUVUE® MOIST', 'Moist'], 'description': 'Commercially available spherical silicone hydrogel contact lenses for daily disposable wear', 'armGroupLabels': ['DD T2/Moist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '30097', 'city': 'Johns Creek', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 34.02893, 'lon': -84.19858}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}