Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT03764735
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2018-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of SkQ1 as Treatment for Dry-eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600714', 'term': 'Visomitin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@mitotechpharma.com', 'phone': '+352621692785', 'title': 'Chief Operating Officer', 'organization': 'Mitotech S.A.'}, 'certainAgreement': {'otherDetails': 'Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor will have the final decision regarding the manuscript and publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day -7 through end of study (Day 57)', 'eventGroups': [{'id': 'EG000', 'title': 'SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 ophthalmic solution', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 3, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Low Dose - SkQ1', 'description': 'SkQ1 Low dose ophthalmic solution', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 4, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'High Dose - SkQ1', 'description': 'SkQ1 High Dose ophthalmic solution', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 3, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral arterial occlusive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 151, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Central Corneal Staining Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 ophthalmic solution'}, {'id': 'OG001', 'title': 'Low Dose - SkQ1', 'description': 'SkQ1 Low dose ophthalmic solution'}, {'id': 'OG002', 'title': 'High Dose - SkQ1', 'description': 'SkQ1 High Dose ophthalmic solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.773', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.816', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.763', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Grittiness Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 ophthalmic solution'}, {'id': 'OG001', 'title': 'Low Dose - SkQ1', 'description': 'SkQ1 Low dose ophthalmic solution'}, {'id': 'OG002', 'title': 'High Dose - SkQ1', 'description': 'SkQ1 High Dose ophthalmic solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.108', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '1.176', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '1.387', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 ophthalmic solution'}, {'id': 'FG001', 'title': 'Low Dose - SkQ1', 'description': 'SkQ1 Low dose ophthalmic solution'}, {'id': 'FG002', 'title': 'High Dose - SkQ1', 'description': 'SkQ1 High Dose ophthalmic solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '451', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SkQ1 Vehicle', 'description': 'Vehicle for SkQ1 ophthalmic solution'}, {'id': 'BG001', 'title': 'Low Dose - SkQ1', 'description': 'SkQ1 Low dose ophthalmic solution'}, {'id': 'BG002', 'title': 'High Dose - SkQ1', 'description': 'SkQ1 High Dose ophthalmic solution'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '12.98', 'groupId': 'BG000'}, {'value': '64.4', 'spread': '12.35', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '13.58', 'groupId': 'BG002'}, {'value': '63.4', 'spread': '13.03', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '316', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '374', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '451', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Central CFS', 'classes': [{'categories': [{'measurements': [{'value': '1.72', 'spread': '0.73', 'groupId': 'BG000'}, {'value': '1.67', 'spread': '0.69', 'groupId': 'BG001'}, {'value': '1.67', 'spread': '0.68', 'groupId': 'BG002'}, {'value': '1.69', 'spread': '0.70', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-13', 'size': 3438693, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-20T16:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel-group study of two strengths of ophthalmic solution versus placebo solution'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-20', 'studyFirstSubmitDate': '2018-11-30', 'resultsFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-20', 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Corneal Staining Change From Baseline', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe'}, {'measure': 'Grittiness Change From Baseline', 'timeFrame': 'From baseline to Day 57', 'description': 'Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye', 'Dry Eye Syndrome', 'SkQ1', 'KCS', 'Keratoconjunctivitis'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.', 'detailedDescription': 'Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).\n\nThe Primary Endpoints are:\n\nChange from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;\n\nChange from Baseline (Visit 2) to Visit 5 in Grittiness Symptom'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent;\n* Have a subject reported history of dry eye;\n* Have a history of use of eye drops for dry eye symptoms ;\n* Ocular Discomfort;\n* Schirmer's Test score;\n* Have corneal fluorescein staining ;\n* Have lissamine green conjunctival Staining ;\n* Have a conjunctival redness;\n\nExclusion Criteria:\n\n* Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;\n* Have any clinically significant slit lamp findings at Visit 1;\n* Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1;\n* Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period;\n* Have an uncontrolled systemic disease;\n* Be a woman who is pregnant, nursing or planning a pregnancy;\n* Be a woman of childbearing potential who is not using an acceptable means of birth control;\n* Have a known allergy and/or sensitivity to the study drug or its components ;\n* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;\n* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;"}, 'identificationModule': {'nctId': 'NCT03764735', 'acronym': 'VISTA-1', 'briefTitle': 'Study of SkQ1 as Treatment for Dry-eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mitotech, SA'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome', 'orgStudyIdInfo': {'id': '18-110-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'SkQ1 Vehicle', 'description': 'SkQ1 (Vehicle)', 'interventionNames': ['Drug: SkQ1 (Vehicle)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose - SkQ1', 'description': 'Low-dose ophthalmic solution', 'interventionNames': ['Drug: Low Dose - SkQ1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose - SkQ1', 'description': 'High-dose ophthalmic solution', 'interventionNames': ['Drug: High dose - SkQ1']}], 'interventions': [{'name': 'Low Dose - SkQ1', 'type': 'DRUG', 'otherNames': ['Visomitin'], 'description': 'SkQ1 Low dose ophthalmic solution', 'armGroupLabels': ['Low Dose - SkQ1']}, {'name': 'High dose - SkQ1', 'type': 'DRUG', 'otherNames': ['Visomitin'], 'description': 'SkQ1 High Dose ophthalmic solution', 'armGroupLabels': ['High Dose - SkQ1']}, {'name': 'SkQ1 (Vehicle)', 'type': 'DRUG', 'description': 'Vehicle for SkQ1 ophthalmic solution', 'armGroupLabels': ['SkQ1 Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea & Cataract Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Eye Care Insititute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '04240', 'city': 'Lewiston', 'state': 'Maine', 'country': 'United States', 'facility': 'Central Maine Eye Care', 'geoPoint': {'lat': 44.10035, 'lon': -70.21478}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '28150', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vita Eye Clinic', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care, PA', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Lawrence T Friedhoff, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mitotech, SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mitotech, SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}