Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-07 @ 12:23 PM
Study NCT ID:
NCT03118934
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'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': 'Head, CDMA Vision Care Franchise', 'organization': 'Alcon, A Novartis Division'}, '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': 'Screening/Fitting through study completion, a maximum of 33 days.', 'description': 'Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set, as exposed, which is different than "as randomized" due to subjects not following the assigned randomization. "At risk" population for ocular AEs is reported in units of eyes.', 'eventGroups': [{'id': 'EG000', 'title': 'AOA MF Ocular', 'description': 'Eyes exposed to AIR OPTIX AQUA® Multifocal (AOA MF) contact lenses', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AOA MF Nonocular', 'description': 'Subjects exposed to AOA MF contact lenses', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DACP MF Ocular', 'description': 'Eyes exposed to DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lenses', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'DACP MF Nonocular', 'description': 'Subjects exposed to DACP MF contact lenses', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'DT1 MF Ocular', 'description': 'Eyes exposed to DAILIES TOTAL1® Multifocal (DT1 MF) contact lenses', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'DT1 MF Nonocular', 'description': 'Subjects exposed to DT1 MF contact lenses', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Trial Lenses Needed to Fit Each Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alternative', 'description': 'Bilaterally fitted with trial lenses using the alternative fitting guide'}, {'id': 'OG001', 'title': 'Current', 'description': 'Bilaterally fitted with trial lenses using the current fitting guide'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).'}], 'paramType': 'MEAN', 'timeFrame': 'VIsit 1/Day 1', 'description': 'The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit', 'unitOfMeasure': 'lenses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AOA MF - Alternative', 'description': 'Bilaterally (in both eyes) fitted using alternative fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'FG001', 'title': 'DACP MF - Alternative', 'description': 'Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'FG002', 'title': 'DT1 MF - Alternative', 'description': 'Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'FG003', 'title': 'AOA MF - Current', 'description': 'Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days'}, {'id': 'FG004', 'title': 'DACP MF - Current', 'description': 'Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'FG005', 'title': 'DT1 MF - Current', 'description': 'Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized and trial fit, as randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '29'}, {'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'Safety Analysis Set', 'comment': 'All subjects/eyes exposed to study lenses, except those used for trial fit at Visit 1, as exposed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '26'}, {'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'comment': 'Completed, as randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Discontinued prior to exposure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).', 'preAssignmentDetails': 'Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AOA MF', 'description': 'Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'BG001', 'title': 'DACP MF', 'description': 'Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'BG002', 'title': 'DT1 MF', 'description': 'Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '50.1', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '50.3', 'spread': '6.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set. Baseline data analyzed based on study lens.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-07', 'size': 1855755, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-03T15:20', 'hasProtocol': False}, {'date': '2017-03-21', 'size': 3353720, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-03T15:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2017-04-11', 'resultsFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2017-04-17', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-28', 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Trial Lenses Needed to Fit Each Eye', 'timeFrame': 'VIsit 1/Day 1', 'description': 'The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['contact lenses', 'presbyopia', 'multifocal'], 'conditions': ['Presbyopia', 'Refractive Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sign informed consent;\n* Normal eyes;\n* Current full-time soft contact lens wearer needing presbyopia correction;\n* Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;\n* Eye conditions (past or present) as specified in the protocol;\n* Currently wearing Alcon multifocal (MF) contact lenses;\n* Only one eye with functional vision;\n* Contact lens wear in one eye only;\n* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03118934', 'briefTitle': 'Assessing Fitting Guides in Alcon Multifocal Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Assessing Fitting Guides in Alcon Multifocal Contact Lenses', 'orgStudyIdInfo': {'id': 'CLK027-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOA MF', 'description': 'Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days', 'interventionNames': ['Device: Lotrafilcon B multifocal contact lenses']}, {'type': 'EXPERIMENTAL', 'label': 'DACP MF', 'description': 'Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days', 'interventionNames': ['Device: Nelfilcon A multifocal contact lenses']}, {'type': 'EXPERIMENTAL', 'label': 'DT1 MF', 'description': 'Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days', 'interventionNames': ['Device: Delefilcon A multifocal contact lenses']}], 'interventions': [{'name': 'Lotrafilcon B multifocal contact lenses', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX AQUA® Multifocal'], 'description': "Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution", 'armGroupLabels': ['AOA MF']}, {'name': 'Nelfilcon A multifocal contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES® AquaComfort Plus® Multifocal'], 'description': 'Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning', 'armGroupLabels': ['DACP MF']}, {'name': 'Delefilcon A multifocal contact lenses', 'type': 'DEVICE', 'otherNames': ['DAILIES TOTAL1® Multifocal'], 'description': 'Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning', 'armGroupLabels': ['DT1 MF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '66204', 'city': 'Shawnee Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 39.02, 'lon': -94.66583}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55344', 'city': 'Eden Prairie', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 44.85469, 'lon': -93.47079}}, {'zip': '55340', 'city': 'Medina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 45.03524, 'lon': -93.58246}}, {'zip': '64133', 'city': 'Raytown', 'state': 'Missouri', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 39.00862, 'lon': -94.46356}}, {'zip': '43065', 'city': 'Powell', 'state': 'Ohio', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 40.15784, 'lon': -83.07519}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38104', '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}}, {'zip': 'V5E 1G3', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'M2N 3A4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M2J2Z1', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'CV49PQ', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'HR1 2PR', 'city': 'Hereford', 'country': 'United Kingdom', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 52.05684, 'lon': -2.71482}}, {'zip': 'NP25 3PS', 'city': 'Monmouth', 'country': 'United Kingdom', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 51.81265, 'lon': -2.71363}}], 'overallOfficials': [{'name': 'Clinical Trial Manager, Vision Care', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}