Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-02 @ 3:00 AM
Study NCT ID:
NCT03417557
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2018-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MNguyen@coopervision.com', 'phone': '19257306716', 'title': 'Myhanh Nguyen, Sr. Optometrist', 'organization': 'CooperVision'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 hours per intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Comfilcon A Lens (Test)', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.\n\nComfilcon A lens (test): contact lens', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Omafilcon B Lens (Control)', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.\n\nOmafilcon B lens (control): contact lens', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Lens (Test)', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.\n\nComfilcon A lens (test): contact lens'}, {'id': 'OG001', 'title': 'Omafilcon B Lens (Control)', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.\n\nOmafilcon B lens (control): contact lens'}], 'classes': [{'title': 'Distance: Binocular', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.16', 'groupId': 'OG001'}]}]}, {'title': 'Distance: Monocular (dominate eye)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Distant: Monocular (non-dominate eye)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Near: Binocular', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Near: Monocular (dominate eye)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Near: Monocular (non-dominate eye)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 hours', 'description': 'Visual acuity is assessed for test and control lens on a logMAR chart', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Lens (Test)', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.\n\nComfilcon A lens (test): contact lens'}, {'id': 'OG001', 'title': 'Omafilcon B Lens (Control)', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.\n\nOmafilcon B lens (control): contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '8', 'groupId': 'OG000'}, {'value': '79', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 hours', 'description': 'Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Lens (Test)', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.\n\nComfilcon A lens (test): contact lens'}, {'id': 'OG001', 'title': 'Omafilcon B Lens (Control)', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.\n\nOmafilcon B lens (control): contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '12', 'groupId': 'OG000'}, {'value': '82', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 hours', 'description': 'Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Comfilcon A Lens (Test)', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours during this cross over study.\n\nComfilcon A lens (test): contact lens'}, {'id': 'OG001', 'title': 'Omafilcon B Lens (Control)', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours during this cross over study.\n\nOmafilcon B lens (control): contact lens'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '17', 'groupId': 'OG000'}, {'value': '79', 'spread': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 3 hours', 'description': 'Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Comfilcon A Lens Then Omafilcon B Lens', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study.\n\nComfilcon A lens (test): contact lens'}, {'id': 'FG001', 'title': 'Omafilcon B Lens Then Comfilcon A', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study.\n\nOmafilcon B lens (control): contact lens'}], 'periods': [{'title': '1st Intervention (3 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '2nd Intervention (3 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Comfilcon A Lens (Test) and Omafilcon B (Control)', 'description': 'Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, either as first or second lens during this cross over study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', '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': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 298633, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-03T20:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'dispFirstSubmitDate': '2019-12-19', 'completionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2018-01-25', 'dispFirstSubmitQcDate': '2020-04-30', 'resultsFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2018-01-25', 'dispFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-30', 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'up to 3 hours', 'description': 'Visual acuity is assessed for test and control lens on a logMAR chart'}], 'secondaryOutcomes': [{'measure': 'Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity', 'timeFrame': 'up to 3 hours', 'description': 'Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.'}, {'measure': 'Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity', 'timeFrame': 'up to 3 hours', 'description': 'Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.'}, {'measure': 'Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity', 'timeFrame': 'up to 3 hours', 'description': 'Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.', 'detailedDescription': 'This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has had a self-reported oculo-visual examination in the last two years.\n* Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.\n* Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.\n* Is able to participate in Parts A and B related to this work.\n* Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).\n* Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).\n* Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.\n* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.\n* Currently wears soft contact lenses.\n* Has clear corneas and no active ocular disease.\n* Has not worn lenses for at least 12 hours before the examination.\n\nExclusion Criteria:\n\nA person will be excluded from the study if he/she:\n\n* Has never worn contact lenses before.\n* Has any systemic disease affecting ocular health.\n* Is using any systemic or topical medications that will affect ocular health.\n* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.\n* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.\n* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.\n* Is aphakic.\n* Has undergone corneal refractive surgery.\n* Is participating in any other type of eye related clinical or research study.'}, 'identificationModule': {'nctId': 'NCT03417557', 'briefTitle': 'Clinical Validation Study of Comfilcon A Multifocal Toric Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses', 'orgStudyIdInfo': {'id': 'CV-18-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comfilcon A lens (test)', 'description': 'Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.', 'interventionNames': ['Device: Comfilcon A lens (test)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omafilcon B Lens (control)', 'description': 'Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.', 'interventionNames': ['Device: Omafilcon B lens (control)']}], 'interventions': [{'name': 'Comfilcon A lens (test)', 'type': 'DEVICE', 'otherNames': ['Biofinity multifocal toric Lens (test)'], 'description': 'contact lens', 'armGroupLabels': ['Comfilcon A lens (test)']}, {'name': 'Omafilcon B lens (control)', 'type': 'DEVICE', 'otherNames': ['Proclear multifocal toric lens (control)'], 'description': 'contact lens', 'armGroupLabels': ['Omafilcon B Lens (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}