Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT05338333
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2022-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003261', 'term': 'Contact Lenses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, '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 (AE's) were collected from time of consent to study exit, approximately 60 days.", 'description': 'AE\'s were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AE\'s is reported in units of eyes according to actual study lens exposure. All other populations are reported in units of subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'Events reported in this group occurred prior to exposure to the study contact lenses', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LID210464 Ocular', 'description': 'Events reported in this group occurred while exposed to the lehfilcon A contact lenses', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LID210464 Non-Ocular', 'description': 'Events reported in this group occurred while exposed to the lehfilcon A contact lenses', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AOHG MF Ocular', 'description': 'Events reported in this group occurred while exposed to the lotrafilcon B contact lenses', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'AOHG MF Non-Ocular', 'description': 'Events reported in this group occurred while exposed to the lotrafilcon B contact lenses', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LID210464', 'description': 'Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1 or Period 2, as randomized, in both eyes for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.'}, {'id': 'OG001', 'title': 'AOHG MF', 'description': 'Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1 or Period 2, as randomized, in both eyes for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.010', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.010', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciUpperLimit': '0.00', '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': '0.006', 'estimateComment': 'LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction, period, sequence, and habitual lens stratum) and random (subject) effects. Difference = LID210464 minus AOHG MF.', '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 wear period. A wear period was approximately 30 days.', 'description': 'Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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': 'Full Analysis Set: All randomized subjects/eyes exposed to any study lenses evaluated in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LID210464, Then AOHG MF', 'description': 'Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting.'}, {'id': 'FG001', 'title': 'AOHG MF, Then LID210464', 'description': 'Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.'}], 'periods': [{'title': 'Period 1, Approximately 30 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '102', 'numSubjects': '51'}, {'groupId': 'FG001', 'numUnits': '100', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '100', 'numSubjects': '50'}, {'groupId': 'FG001', 'numUnits': '100', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Approximately 30 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '100', 'numSubjects': '50'}, {'groupId': 'FG001', 'numUnits': '100', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '100', 'numSubjects': '50'}, {'groupId': 'FG001', 'numUnits': '100', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Participants were recruited from 8 investigative sites located in the United States.', 'preAssignmentDetails': 'This reporting group includes all enrolled participants, as treated (101). Note, one subject that was randomized to AOHG MF, then LID210464 was exposed to LID210464, then AOHG MF instead.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LID210464, Then AOHG MF', 'description': 'Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for daily contact lens cleaning and disinfecting.'}, {'id': 'BG001', 'title': 'AOHG MF, Then LID210464', 'description': 'Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type was worn bilaterally (in both eyes) for 30 days. CLEAR CARE® was used for nightly contact lens cleaning and disinfecting.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '50.0', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '50.8', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study according to actual study lens exposure.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-31', 'size': 1691676, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-21T09:53', 'hasProtocol': True}, {'date': '2022-09-26', 'size': 1144158, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-21T09:53', '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': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2022-04-14', 'resultsFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-23', 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses', 'timeFrame': 'Day 30, each wear period. A wear period was approximately 30 days.', 'description': 'Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together 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': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact lenses', 'Multifocal'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.', 'detailedDescription': 'Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.\n* Willing and able to attend all study visits as required by the protocol.\n* Willing to stop wearing habitual contact lenses for the duration of the study.\n* Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.\n* Other protocol-specified inclusion criteria may apply.\n\nKey Exclusion Criteria:\n\n* Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.\n* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.\n* History of refractive surgery or planning to have refractive surgery during the study.\n* Current or history of pathologically dry eye.\n* Currently pregnant or lactating.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05338333', 'briefTitle': 'Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'CLN705-C001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LID210464, then AOHG MF', 'description': 'Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.', 'interventionNames': ['Device: Lehfilcon A multifocal contact lenses', 'Device: Lotrafilcon B multifocal contact lenses', 'Device: CLEAR CARE®']}, {'type': 'OTHER', 'label': 'AOHG MF, then LID210464', 'description': 'Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.', 'interventionNames': ['Device: Lehfilcon A multifocal contact lenses', 'Device: Lotrafilcon B multifocal contact lenses', 'Device: CLEAR CARE®']}], 'interventions': [{'name': 'Lehfilcon A multifocal contact lenses', 'type': 'DEVICE', 'otherNames': ['LID210464'], 'description': 'Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia', 'armGroupLabels': ['AOHG MF, then LID210464', 'LID210464, then AOHG MF']}, {'name': 'Lotrafilcon B multifocal contact lenses', 'type': 'DEVICE', 'otherNames': ['AOHG MF', 'AIR OPTIX® plus HydraGlyde® Multifocal (AOHG MF) contact lenses'], 'description': 'Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia', 'armGroupLabels': ['AOHG MF, then LID210464', 'LID210464, then AOHG MF']}, {'name': 'CLEAR CARE®', 'type': 'DEVICE', 'description': 'Hydrogen peroxide-based contact lens cleaning and disinfecting solution', 'armGroupLabels': ['AOHG MF, then LID210464', 'LID210464, then AOHG MF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Kindred Optics at Maitland Vision', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Vision Health Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kannarr Eye Care LLC', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'The Eye Doctors, Inc.', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}, {'zip': '55340', 'city': 'Medina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Complete Eye Care of Medina', 'geoPoint': {'lat': 45.03524, 'lon': -93.58246}}, {'zip': '43023', 'city': 'Granville', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProCare Vision Centers, Inc.', 'geoPoint': {'lat': 40.06812, 'lon': -82.5196}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'West Bay Eye Associates', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38111', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Optometry Group, PLLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], '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'}}}}