Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-28 @ 2:12 PM
Study NCT ID:
NCT04178720
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'CDMA 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 (AE's) were collected from time of consent to study exit, approximately 3 months.", 'description': 'AE\'s 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 participants. This analysis population includes all enrolled and dispensed subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-treatment', 'description': 'Events reported in this group occurred prior to exposure to the study contact lenses', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LID018869 Ocular', 'description': 'Events reported in this group occurred while exposed to lehfilcon A contact lenses', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LID018869 Nonocular/Systemic', 'description': 'Events reported in this group occurred while exposed to lehfilcon A contact lenses', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Biofinity Ocular', 'description': 'Events reported in this group occurred while exposed to comfilcon A contact lenses', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Biofinity Nonocular/Systemic', 'description': 'Events reported in this group occurred while exposed to comfilcon A contact lenses', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distance VA (logMAR) With Study Lenses - Completed Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours onl, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}, {'id': 'OG001', 'title': 'LID018869', 'description': 'Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}], 'classes': [{'title': 'Dispense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 follow-up Snellen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)', 'description': 'Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all enrolled and dispensed subjects/eyes that completed the study with data at corresponding in-person visit.'}, {'type': 'PRIMARY', 'title': 'Distance VA (logMAR) With Study Lenses - Discontinued Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours onl, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}, {'id': 'OG001', 'title': 'LID018869', 'description': 'Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}], 'classes': [{'title': 'Dispense', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up', 'description': 'Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'This analysis population includes all enrolled and dispensed subjects/eyes that discontinued the study early with data at corresponding in-person visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}, {'id': 'FG001', 'title': 'LID018869', 'description': 'Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '80', 'numSubjects': '40'}, {'groupId': 'FG001', 'numUnits': '156', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '76', 'numSubjects': '38'}, {'groupId': 'FG001', 'numUnits': '154', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Subjects were enrolled at 8 investigative sites located in the US.', 'preAssignmentDetails': 'Of the 119 enrolled, 1 subject was screen failed. This reporting group includes all enrolled and dispensed subjects/eyes (118/236).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}, {'id': 'BG001', 'title': 'LID018869', 'description': 'Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only, as randomized. Lenses were removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '33.9', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '112', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': '40', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This analysis population includes all enrolled and dispensed subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-08', 'size': 2934334, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-22T08:57', 'hasProtocol': True}, {'date': '2020-07-21', 'size': 1489507, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-22T08:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2019-11-25', 'resultsFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-12', 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance VA (logMAR) With Study Lenses - Completed Eyes', 'timeFrame': 'Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up, Month 2 follow-up, Month 3 follow-up (at least 4 hours after lens insertion at each follow-up assessment visit)', 'description': 'Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.'}, {'measure': 'Distance VA (logMAR) With Study Lenses - Discontinued Eyes', 'timeFrame': 'Dispense, Week 1 follow-up, Week 2 follow-up, Month 1 follow-up', 'description': 'Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact Lens', 'Daily Wear', 'Vision Correction'], 'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to evaluate the safety and effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.', 'detailedDescription': 'Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.\n* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.\n* Other protocol-specified inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.\n* Habitually wearing Biofinity contact lenses.\n* Monovision contact lens wearers.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04178720', 'briefTitle': 'Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens', 'orgStudyIdInfo': {'id': 'CLY935-C010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LID018869', 'description': 'Lehfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.', 'interventionNames': ['Device: Lehfilcon A contact lenses', 'Device: CLEAR CARE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biofinity', 'description': 'Comfilcon A contact lenses worn in both eyes at least approximately 8 hours per day and approximately 5 days per week during waking hours only. The lenses will be removed nightly for cleaning and disinfection and replaced monthly over the 3-month wear period.', 'interventionNames': ['Device: Comfilcon A contact lenses', 'Device: CLEAR CARE']}], 'interventions': [{'name': 'Lehfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['LID018869'], 'description': 'Investigational silicone hydrogel contact lenses', 'armGroupLabels': ['LID018869']}, {'name': 'Comfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['CooperVision® BIOFINITY®', 'Biofinity'], 'description': 'Commercially available silicone hydrogel contact lenses', 'armGroupLabels': ['Biofinity']}, {'name': 'CLEAR CARE', 'type': 'DEVICE', 'otherNames': ['CLEAR CARE® Cleaning & Disinfecting Solution'], 'description': 'Hydrogen peroxide-based system for cleaning and disinfecting silicone hydrogel contact lenses', 'armGroupLabels': ['Biofinity', 'LID018869']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '61704', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '55340', 'city': 'Medina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 45.03524, 'lon': -93.58246}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'CDMA Project Lead, Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}