Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-11 @ 4:09 PM
Study NCT ID:
NCT03333057
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@novaliq.com', 'phone': '+49 6221 50259', 'title': 'Dr. Sonja Kroesser', 'phoneExt': '0', 'organization': 'Novaliq GmbH'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'whole study duration (8 weeks per patient)', 'eventGroups': [{'id': 'EG000', 'title': 'NOV03 2 Times Daily (BID)', 'description': 'Perfluorohexyloctance solution 2 times daily (BID)\n\nNOV03: Perfluorohexyloctane', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 1, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'NOV03 4 Times Daily (QID)', 'description': 'Perfluorohexyloctance solution 4 times daily\n\nNOV03: Perfluorohexyloctane', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 4, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo BID/QID', 'description': 'Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)\n\nPlacebo: Saline solution (0.9% sodium chloride solution)', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 3, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Instillation site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NOV03 2 Times Daily (BID)', 'description': 'Perfluorohexyloctance solution 2 times daily (BID)\n\nNOV03: Perfluorohexyloctane'}, {'id': 'OG001', 'title': 'NOV03 4 Times Daily (QID)', 'description': 'Perfluorohexyloctance solution 4 times daily\n\nNOV03:Perfluorohexyloctane'}, {'id': 'OG002', 'title': 'Placebo BID/QID', 'description': 'Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)\n\nPlacebo: Saline solution (0.9% sodium chloride solution)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'groupId': 'OG000', 'lowerLimit': '-2.27', 'upperLimit': '-1.30'}, {'value': '-2.11', 'groupId': 'OG001', 'lowerLimit': '-2.59', 'upperLimit': '-1.63'}, {'value': '-0.93', 'groupId': 'OG002', 'lowerLimit': '-1.41', 'upperLimit': '-0.45'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 2 months', 'description': 'The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8\n\nThe NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NOV03 2 Times Daily (BID)', 'description': 'Perfluorohexyloctance solution 2 times daily (BID)\n\nNOV03: Perfluorohexyloctane'}, {'id': 'FG001', 'title': 'NOV03 4 Times Daily (QID)', 'description': 'Perfluorohexyloctance solution 4 times daily\n\nNOV03: Perfluorohexyloctane'}, {'id': 'FG002', 'title': 'Placebo BID/QID', 'description': 'Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)\n\nPlacebo: Saline solution (0.9% sodium chloride solution)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '336', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'NOV03 2 Times Daily (BID)', 'description': 'Perfluorohexyloctance solution 2 times daily (BID)\n\nNOV03: Perfluorohexyloctane'}, {'id': 'BG001', 'title': 'NOV03 4 Times Daily (QID)', 'description': 'Perfluorohexyloctance solution 4 times daily\n\nNOV03: Perfluorohexyloctane'}, {'id': 'BG002', 'title': 'Placebo BID/QID', 'description': 'Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)\n\nPlacebo: Saline solution (0.9% sodium chloride solution)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '86'}, {'value': '53.0', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '86'}, {'value': '53.8', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '85'}, {'value': '53.6', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '259', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', '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': '111', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '336', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-07', 'size': 1231467, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-29T06:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2019-06-07', 'completionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2017-11-02', 'dispFirstSubmitQcDate': '2019-06-07', 'resultsFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2017-11-02', 'dispFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-30', 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)', 'timeFrame': 'baseline and 2 months', 'description': 'The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8\n\nThe NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease (DED)']}, 'referencesModule': {'references': [{'pmid': '33369937', 'type': 'RESULT', 'citation': 'Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krosser S; SEECASE study group. A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease. Cornea. 2021 Sep 1;40(9):1132-1140. doi: 10.1097/ICO.0000000000002622.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/33369937/', 'label': 'Publication of Study Results in Cornea'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed ICF (Informed Consent Form)\n* Subject-reported history of Drye Eye Disease (DED) in both eyes\n* Ability and willingness to follow instructions, including participation in all study assessments and visits\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing or planning pregnancy\n* Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control\n* Clinically significant slit-lamp findings or abnormal lid anatomy at screening\n* Ocular/peri-ocular malignancy\n* History of herpetic keratitis\n* Active ocular allergies or ocular allergies that are expected to be active during the study\n* Ongoing ocular or systemic infection\n* Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study\n* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period\n* Presence of uncontrolled systemic diseases\n* Presence of known allergy and/or sensitivity to the study drug or saline components\n* Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening'}, 'identificationModule': {'nctId': 'NCT03333057', 'briefTitle': 'Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novaliq GmbH'}, 'officialTitle': 'A Phase 2, Multi-Center, Randomized, Double-Masked, Saline-Controlled Study to Evaluate the Effect of Perfluorohexyloctane (NOV03) at Two Different Dosing Regimens on Signs and Symptoms of Dry Eye Disease (DED)', 'orgStudyIdInfo': {'id': 'NVU-002 (SEECASE)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NOV03 4 times daily (QID)', 'description': 'Perfluorohexyloctance solution 4 times daily (QID)', 'interventionNames': ['Drug: NOV03']}, {'type': 'EXPERIMENTAL', 'label': 'NOV03 2 times daily (BID)', 'description': 'Perfluorohexyloctance solution 2 times daily (BID)', 'interventionNames': ['Drug: NOV03']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 4 times daily (QID)', 'description': 'Saline solution (0.9% sodium chloride solution) 4 times daily (QID)', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 2 times daily (BID)', 'description': 'Saline solution (0.9% sodium chloride solution) 2 times daily (BID)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NOV03', 'type': 'DRUG', 'description': 'Perfluorohexyloctane', 'armGroupLabels': ['NOV03 2 times daily (BID)', 'NOV03 4 times daily (QID)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline solution (0.9% sodium chloride solution)', 'armGroupLabels': ['Placebo 2 times daily (BID)', 'Placebo 4 times daily (QID)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Investigational site', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60046', 'city': 'Lake Villa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 42.41697, 'lon': -88.07397}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08534', 'city': 'Pennington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 40.32844, 'lon': -74.79072}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Sonja Kroesser, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novaliq GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novaliq GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}