Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06165627
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2023-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr. Clinical Project Lead, Vision Care', 'organization': 'Alcon Research, LLC'}, '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': 'Adverse Events (AEs) were collected from time of consent to study exit, up to 74 days.', 'description': 'AEs were obtained through solicited and spontaneous comments from subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'Events reported in this group occurred before exposure to study lenses.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'T30fA Ocular', 'description': 'Events reported in this group occurred while exposed to lehfilcon A toric contact lenses.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'T30fA Nonocular', 'description': 'Events reported in this group occurred while exposed to lehfilcon A toric contact lenses.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Biofinity Toric Ocular', 'description': 'Events reported in this group occurred while exposed to comfilcon A toric contact lenses.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Biofinity Toric Nonocular', 'description': 'Events reported in this group occurred while exposed to comfilcon A toric contact lenses.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Distance Visual Acuity With Study Lenses at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T30fA', 'description': 'Lehfilcon A toric contact lenses worn in Period 1 and worn in Period 2, as randomized.'}, {'id': 'OG001', 'title': 'Biofinity Toric', 'description': 'Comfilcon A toric contact lenses worn in Period 1 and worn in Period 2, as randomized.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.', 'description': 'Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response. Note, One subject in the Biofinity Toric arm lost a lens on the way to the visit. Hence, the assessment was taken on 1 eye only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T30fA, Then Biofinity Toric', 'description': 'Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \\[-1/+3\\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \\& Disinfecting Solution.'}, {'id': 'FG001', 'title': 'Biofinity Toric, Then T30fA', 'description': 'Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \\[-1/+3\\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \\& Disinfecting Solution.'}], 'periods': [{'title': 'First Wear Period (Approx. 30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '34'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '34'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Second Wear Period (Approx. 30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '34'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '68', 'numSubjects': '34'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'preAssignmentDetails': 'Of the 67 enrolled, 1 participant was discontinued following randomization but prior to exposure to the study lenses. This reporting group includes all participants exposed to any study lenses evaluated in this study (66).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T30fA, Then Biofinity Toric', 'description': 'Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \\[-1/+3\\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \\& Disinfecting Solution.'}, {'id': 'BG001', 'title': 'Biofinity Toric, Then T30fA', 'description': 'Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses were worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \\[-1/+3\\] according to randomization assignment). Study lenses were removed daily for cleaning and disinfection with CLEAR CARE Cleaning \\& Disinfecting Solution.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '31.9', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Multi-racial', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-15', 'size': 1075789, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-06T11:52', 'hasProtocol': True}, {'date': '2024-05-03', 'size': 714415, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-06T11:52', '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': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2023-12-04', 'resultsFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-27', 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Distance Visual Acuity With Study Lenses at Day 30', 'timeFrame': 'Day 30 of each wear period. A wear period was 30 days [-1/+3 days] according to randomization assignment.', 'description': 'Visual Acuity (VA) was assessed for each eye individually with study lenses in place while reading letter charts. VA was recorded in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with lower logMAR values representing better eyesight.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lenses', 'Myopia'], 'conditions': ['Ametropia', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.', 'detailedDescription': "Subjects will be expected to attend 5 office visits and will be dispensed study lenses (per randomization sequence) for 30-day duration of bilateral wear with each study lens (approximately 60 days of lens wear). The total duration of the subject's participation in the study will be approximately 74 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;\n* Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;\n* Willing and able to wear the study lenses as specified in the protocol;\n* Other protocol-specified inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;\n* Monovision and multifocal contact lens wearers;\n* Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;\n* Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06165627', 'briefTitle': 'Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses', 'orgStudyIdInfo': {'id': 'CLV201-P003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'T30fA, then Biofinity Toric', 'description': 'Lehfilcon A toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \\[-1/+3\\] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \\& Disinfecting Solution.', 'interventionNames': ['Device: Lehfilcon A toric contact lenses', 'Device: Comfilcon A toric contact lenses', 'Device: CLEAR CARE']}, {'type': 'OTHER', 'label': 'Biofinity Toric, then T30fA', 'description': 'Comfilcon A toric contact lenses worn in Period 1, with lehfilcon A toric contact lenses worn in Period 2, as randomized. The study lenses will be worn bilaterally (in both eyes) during waking hours for at least 12 hours per day during each wear period (30 days \\[-1/+3\\] according to randomization assignment). Study lenses will be removed daily for cleaning and disinfection with CLEAR CARE Cleaning \\& Disinfecting Solution.', 'interventionNames': ['Device: Lehfilcon A toric contact lenses', 'Device: Comfilcon A toric contact lenses', 'Device: CLEAR CARE']}], 'interventions': [{'name': 'Lehfilcon A toric contact lenses', 'type': 'DEVICE', 'otherNames': ['TOTAL30™ for Astigmatism', 'T30fA'], 'description': 'Commercially available soft contact lenses worn as indicated', 'armGroupLabels': ['Biofinity Toric, then T30fA', 'T30fA, then Biofinity Toric']}, {'name': 'Comfilcon A toric contact lenses', 'type': 'DEVICE', 'otherNames': ['Biofinity® Toric', 'Biofinity Toric'], 'description': 'Commercially available soft contact lenses) worn as indicated', 'armGroupLabels': ['Biofinity Toric, then T30fA', 'T30fA, then Biofinity Toric']}, {'name': 'CLEAR CARE', 'type': 'DEVICE', 'otherNames': ['CLEAR CARE® Cleaning & Disinfecting Solution'], 'description': 'Commercially available hydrogen peroxide-based solution for daily cleaning and disinfection of contact lenses used as indicated', 'armGroupLabels': ['Biofinity Toric, then T30fA', 'T30fA, then Biofinity Toric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90012', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kurata Eye Care Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94607', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Elsa Pao, OD', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94127', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Rims Optometry', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Vision Health Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProCare Vision Center', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}], 'overallOfficials': [{'name': 'Clinical Trial Lead, Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}