Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT04980456
Status:
COMPLETED
Last Update Posted:
2023-01-06
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'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 65 days.", '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 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 prior to exposure to the study contact lenses', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 0, 'seriousNumAtRisk': 249, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TOTAL30 Ocular', 'description': 'Events reported in this group occurred while exposed to the lehfilcon A contact lenses', 'otherNumAtRisk': 490, 'deathsNumAtRisk': 490, 'otherNumAffected': 0, 'seriousNumAtRisk': 490, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TOTAL30 Nonocular', 'description': 'Events reported in this group occurred while exposed to the lehfilcon A contact lenses', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 0, 'seriousNumAtRisk': 245, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Biofinity Ocular', 'description': 'Events reported in this group occurred while exposed to the comfilcon A contact lenses', 'otherNumAtRisk': 492, 'deathsNumAtRisk': 492, 'otherNumAffected': 0, 'seriousNumAtRisk': 492, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Biofinity Nonocular', 'description': 'Events reported in this group occurred while exposed to the comfilcon A contact lenses', 'otherNumAtRisk': 246, 'deathsNumAtRisk': 246, 'otherNumAffected': 0, 'seriousNumAtRisk': 246, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 490, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 492, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Least Squares Mean Distance VA (logMAR) With Study Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TOTAL30', 'description': 'Lehfilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 30 days at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.'}, {'id': 'OG001', 'title': 'Biofinity', 'description': 'Comfilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 30 days at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.005', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciUpperLimit': '0.01', 'pValueComment': 'Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.003', 'estimateComment': 'LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and sequence) and random (subject) effects. Difference = TOTAL30 minus Biofinity', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 30, each study product', 'description': 'Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing response (eye)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TOTAL30, Then Biofinity', 'description': 'Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.'}, {'id': 'FG001', 'title': 'Biofinity, Then TOTAL30', 'description': 'Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.'}], 'periods': [{'title': 'Period 1 (Approximately 30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '244', 'numSubjects': '122'}, {'groupId': 'FG001', 'numUnits': '254', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '238', 'numSubjects': '119'}, {'groupId': 'FG001', 'numUnits': '248', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Period 2 (Approximately 30 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '238', 'numSubjects': '119'}, {'comment': 'One subject (2 eyes) discontinued after completing first period and prior to exposure to second period product due to an adverse event.', 'groupId': 'FG001', 'numUnits': '246', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '238', 'numSubjects': '119'}, {'groupId': 'FG001', 'numUnits': '244', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'This study was conducted at 14 investigative sites located in the United States.', 'preAssignmentDetails': 'Of the 257 enrolled, 8 subjects were exited prior to randomization as screen failures. This reporting group includes all subjects exposed to the study lenses, as treated (249). Note: One subject randomized to TOTAL30, then Biofinity was exposed to the incorrect study lenses in the sequence (Biofinity, then TOTAL30).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TOTAL30, Then Biofinity', 'description': 'Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.'}, {'id': 'BG001', 'title': 'Biofinity, Then TOTAL30', 'description': 'Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '33.1', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '232', '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': '80', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', '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': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Multi-racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', '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': '123', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects exposed to any study lenses evaluated in this study, as randomized'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-28', 'size': 5079168, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-16T11:29', 'hasProtocol': True}, {'date': '2021-07-29', 'size': 1354830, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-16T11:31', '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': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2021-07-19', 'resultsFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-13', 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least Squares Mean Distance VA (logMAR) With Study Lenses', 'timeFrame': 'Day 30, each study product', 'description': 'Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lenses'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.', 'detailedDescription': 'Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand and sign an approved Informed Consent form;\n* Willing and able to attend all scheduled study visits as required by the protocol;\n* Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;\n* Manifest cylinder less than or equal to 0.75 diopter (D) 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 that contraindicates contact lens wear, as determined by the Investigator;\n* Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;\n* Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;\n* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;\n* Current or prior Biofinity contact lens wear in the past 3 months prior to consent.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04980456', 'briefTitle': 'Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses', 'orgStudyIdInfo': {'id': 'CLY935-C019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TOTAL30, then Biofinity', 'description': 'Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses as randomized. Each study product will be worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.', 'interventionNames': ['Device: Lehfilcon A contact lenses', 'Device: Comfilcon A contact lenses', 'Device: CLEAR CARE']}, {'type': 'OTHER', 'label': 'Biofinity, then TOTAL30', 'description': 'Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product will be worn bilaterally (in both eyes) for at least 10 hours per day during waking hours only. CLEAR CARE will be used for daily cleaning and disinfection.', 'interventionNames': ['Device: Lehfilcon A contact lenses', 'Device: Comfilcon A contact lenses', 'Device: CLEAR CARE']}], 'interventions': [{'name': 'Lehfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['TOTAL30'], 'description': 'Investigational silicone hydrogel contact lenses', 'armGroupLabels': ['Biofinity, then TOTAL30', 'TOTAL30, then Biofinity']}, {'name': 'Comfilcon A contact lenses', 'type': 'DEVICE', 'otherNames': ['CooperVision® Biofinity®', 'Biofinity'], 'description': 'Commercially available silicone hydrogel contact lenses', 'armGroupLabels': ['Biofinity, then TOTAL30', 'TOTAL30, then Biofinity']}, {'name': 'CLEAR CARE', 'type': 'DEVICE', 'description': 'Hydrogen peroxide-based cleaning and disinfecting solution', 'armGroupLabels': ['Biofinity, then TOTAL30', 'TOTAL30, then Biofinity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90012', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Alcon Investigator 8135', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94607', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alcon Investigator 8062', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94127', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Alcon Investigator 8106', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32779', 'city': 'Longwood', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigator 6356', 'geoPoint': {'lat': 28.70305, 'lon': -81.3384}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigator 6565', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33405', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigator 6654', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Alcon Investigator 6567', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Alcon Investigator 5582', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48312', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Alcon Investigator 8097', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '56201', 'city': 'Willmar', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Alcon Investigator 7980', 'geoPoint': {'lat': 45.12191, 'lon': -95.04334}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Alcon Investigator 8130', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Alcon Investigator 6401', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Alcon Investigator 6353', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Investigator 8175', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], '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'}}}}