Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
Study NCT ID:
NCT05393895
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2022-05-10
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016173', 'term': 'Macrophage Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'iris.meisner@orasis-pharma.com', 'phone': '+972-9-8877745', 'title': 'Head of Regulatory Affairs', 'organization': 'Orasis Pharmaceuticals, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.', 'eventGroups': [{'id': 'EG000', 'title': 'CSF-1', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nCSF-1: One drop bilaterally twice daily for at least 6 weeks', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 21, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nVehicle: One drop bilaterally twice daily for at least 6 weeks', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 15, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival hyperaemia', 'notes': 'All cases were mild in the CSF-1 and vehicle group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Conjuctival papillae', 'notes': 'All cases were mild in the CSF-1 and vehicle group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vision blurred', 'notes': 'All cases were mild in the CSF-1 and vehicle group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Instillation site pain', 'notes': 'All cases were mild, with 80% of them being described as stinging or burning, lasting between a few seconds and a minute.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19', 'notes': 'All cases were mild in the CSF-1 and vehicle group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSF-1', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nCSF-1: One drop bilaterally twice daily for at least 6 weeks'}, {'id': 'OG001', 'title': 'Vehicle', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nVehicle: One drop bilaterally twice daily for at least 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.', 'description': 'As this is a safety study, no efficacy outcome has been defined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CSF-1', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nCSF-1: One drop bilaterally twice daily for at least 6 weeks'}, {'id': 'FG001', 'title': 'Vehicle', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nVehicle: One drop bilaterally twice daily for at least 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '236', 'numSubjects': '118'}, {'groupId': 'FG001', 'numUnits': '120', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '220', 'numSubjects': '110'}, {'groupId': 'FG001', 'numUnits': '100', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '16', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'units': 'eyes', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CSF-1', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nCSF-1: One drop bilaterally twice daily for at least 6 weeks'}, {'id': 'BG001', 'title': 'Vehicle', 'description': 'One drop bilaterally twice daily for at least 6 weeks\n\nVehicle: One drop bilaterally twice daily for at least 6 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '5.52', 'groupId': 'BG000'}, {'value': '54.3', 'spread': '5.55', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '5.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': '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': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '140', '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', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Iris Color', 'classes': [{'title': 'Light Iris Color', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Dark Iris Color', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Manifest Refraction Spherical Equivalent (MRSE)', 'classes': [{'title': '-4.5D to <-0.5D', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': '-0.5D to <= +0.75D', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': '> +0.75D to +2.0D', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'MRSE: is the measure which allows to identify if a person is myopic (nearsighted) \\< -0.5D; emmetropic (normal refractive condition) between -0.5D to \\<= +0.75D: or hyperopic (farsighted) \\>+0.75D.\n\nFor this measure, only 1 eye per participant was considered: the worst of both eyes or, if equal, the right eye.', 'unitOfMeasure': 'eyes', 'denomUnitsSelected': 'eyes'}], 'typeUnitsAnalyzed': 'eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-20', 'size': 798316, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-30T05:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2022-05-10', 'resultsFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events.', 'timeFrame': 'Adverse events were collected over a period of at least 6 weeks and up to 21 weeks for the last participants exiting the study.', 'description': 'As this is a safety study, no efficacy outcome has been defined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have presbyopia\n\nExclusion Criteria:\n\n* Have any contraindications to the study medications or diagnoses that would confound the study data'}, 'identificationModule': {'nctId': 'NCT05393895', 'briefTitle': 'An Evaluation of the Safety of CSF-1 in Presbyopic Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orasis Pharmaceuticals Ltd.'}, 'officialTitle': 'A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects', 'orgStudyIdInfo': {'id': '21-150-0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSF-1', 'description': 'One drop bilaterally twice daily for at least 6 weeks', 'interventionNames': ['Drug: CSF-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'One drop bilaterally twice daily for at least 6 weeks', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'CSF-1', 'type': 'DRUG', 'otherNames': ['Qlosi'], 'description': 'One drop bilaterally twice daily for at least 6 weeks', 'armGroupLabels': ['CSF-1']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'One drop bilaterally twice daily for at least 6 weeks', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '27909', 'city': 'Elizabeth City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 36.2946, 'lon': -76.25105}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78613', 'city': 'Cedar Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Orasis Investigative Site', 'geoPoint': {'lat': 30.5052, 'lon': -97.82029}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orasis Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}