Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-07 @ 9:26 PM
Study NCT ID:
NCT06328660
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JVega2@coopervision.com', 'phone': '+1 (925) 621-3761', 'title': 'José A. Vega', 'organization': 'CooperVision Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of the study, approximately 1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Lens 1', 'description': 'Participants that received Lens 1', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 4, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lens 2', 'description': 'Participants that received Lens 2', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 6, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchy Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Lens Handling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'Participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'Participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '96.0', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '21.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 week', 'description': "The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall logMAR Visual Acuity - Dominant Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'Participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'Participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall logMAR Visual Acuity - Non-Dominant Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'Participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'Participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall logMAR Visual Acuity - Binocular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lens 1', 'description': 'Participants that received Lens 1'}, {'id': 'OG001', 'title': 'Lens 2', 'description': 'Participants that received Lens 2'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Frequent Replacement Silicone Hydrogel Contact Lens (Lens 1)', 'description': 'All participants wore Lens 1 for 14 ± 3 days (Period 1)'}, {'id': 'FG001', 'title': 'Daily Disposable Silicone Hydrogel Contact Lens (Lens 2)', 'description': 'All participants wore Lens 2 for 14 ± 3 days (Period 2)'}], 'periods': [{'title': 'Lens 1, 14 ± 3 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'comment': 'All participants received Lens 1 in Period 1.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Lens 2, 14 ± 3 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants received Lens 2 in Period 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 67 potential participants were screened, one participant did not fulfil the entry criteria (prescription out of range).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Includes study participants that completed all study visits'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.9', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', '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': '2023-12-11', 'size': 2350412, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-15T16:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-03-12', 'resultsFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2024-03-18', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-30', 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Lens Handling', 'timeFrame': '1 week', 'description': "The ease of contact lens insertion and removal over the week preceding the follow-up visit measured on a 100-point visual analog scale, where 0=Very difficult, Painful and 100=Very easy, Can't feel the lenses"}], 'secondaryOutcomes': [{'measure': 'Overall logMAR Visual Acuity - Dominant Eye', 'timeFrame': '14 days', 'description': 'The mean logMAR visual acuity of the dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.'}, {'measure': 'Overall logMAR Visual Acuity - Non-Dominant Eye', 'timeFrame': '14 days', 'description': 'The mean logMAR visual acuity of the non-dominant eye calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.'}, {'measure': 'Overall logMAR Visual Acuity - Binocular', 'timeFrame': '14 days', 'description': 'The mean binocular logMAR visual acuity calculated as the mean of distance, intermediate, and near logMAR visual acuities. This value was recorded at the follow-up visit.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare ease of handling and vision acuity of two multifocal contact lenses to correct presbyopia that are currently CE marked and on the UK market.', 'detailedDescription': 'This was an interventional, prospective, open label, sequential design study. Participants wore each study contact lens on a daily disposable wearing modality for 14 ± 3 days and attended the clinic for a total of three study visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 40 years and older;\n2. Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal);\n3. Spectacle refraction:\n\n * Distance: Sphere: -6.00D to + 4.00D\n * Astigmatism: 0.00D to -0.75D\n * Near Addition: Low +0.75D to +1.25D; Medium +1.50D and +1.75D; High +2.00D to +2.50D\n4. Best corrected visual acuity of at least 20/25 in each eye. - The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.\n\nExclusion Criteria:\n\nTo be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study:\n\n1. Acute and subacute inflammation or infection of the anterior chamber of the eye.\n2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear;\n3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic\n4. Severe insufficiency of lacrimal secretion (dry eyes).\n5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema).\n6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions\n7. Any active corneal infection (bacterial, fungal, protozoal or viral).\n8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator;\n9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens;\n10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;\n11. History of corneal refractive surgery\n12. Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.\n13. Current wearer of the test contact lens, MyDay® Multifocal."}, 'identificationModule': {'nctId': 'NCT06328660', 'briefTitle': 'Refitting Multifocal Contact Lens Wearers With a Different Multifocal Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Refitting Biofinity Multifocal Contact Lens Wearer With MyDay Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'EX-MKTG-155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lens 1', 'description': 'All participants wore Lens 1 for 14 ± 3 days (Period 1)', 'interventionNames': ['Device: Lens 1']}, {'type': 'EXPERIMENTAL', 'label': 'Lens 2', 'description': 'All participants wore Lens 2 for 14 ± 3 days (Period 2)', 'interventionNames': ['Device: Lens 2']}], 'interventions': [{'name': 'Lens 1', 'type': 'DEVICE', 'description': 'Frequent replacement silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality', 'armGroupLabels': ['Lens 1']}, {'name': 'Lens 2', 'type': 'DEVICE', 'description': 'Daily disposable silicone hydrogel contact lens for 14 ± 3 days on a daily disposable wearing modality', 'armGroupLabels': ['Lens 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW1E6AU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Ocular Technology Group - International', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Michel Guillon, PhD FCOptom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'mguillon@otg.co.uk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision International Limited (CVIL)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}