Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-13 @ 2:30 PM
Study NCT ID:
NCT04147650
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
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{'timeFrame': 'Day 1 to Week 13', 'eventGroups': [{'id': 'EG000', 'title': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 29, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '0.10% VOS', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 42, 'seriousNumAtRisk': 126, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '0.20% VOS', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 44, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks\n\nVehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 8, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 43, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 47, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'seriousEvents': [{'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'OG001', 'title': '0.10% VOS', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'OG002', 'title': '0.20% VOS', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'OG003', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks\n\nVehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1352', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '0.62', 'ciUpperLimit': '7.62', 'groupDescription': '0.05 % VOS versus vehicle', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2823', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '0.49', 'ciUpperLimit': '6.45', 'groupDescription': '0.10% VOS versus vehicle', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0889', 'groupIds': ['OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '0.70', 'ciUpperLimit': '8.30', 'groupDescription': '0.20% VOS versus vehicle', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '4 Weeks', 'description': 'Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (mITT) number of subjects achieving ≥10 mm increase improvement at week 4'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eye Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'OG001', 'title': '0.10% VOS', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'OG002', 'title': '0.20% VOS', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'OG003', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks\n\nVehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.6', 'spread': '21.80', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '20.00', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '17.68', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': '17.59', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3604', 'groupIds': ['OG000'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '4.3', 'groupDescription': '0.05% VOS versus vehicle', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3737', 'groupIds': ['OG001'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '4.4', 'groupDescription': '0.10% VOS versus vehicle', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5307', 'groupIds': ['OG002'], 'paramType': 'Least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '8.6', 'groupDescription': '0.20% VOS versus vehicle', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Value at 4 Weeks minus value at baseline', 'description': 'Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using all mITT subjects with a baseline eye dryness VAS ≥60 mm. Subjects without a Week 4 eye dryness VAS score were not included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'FG001', 'title': '0.10% VOS', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'FG002', 'title': '0.20% VOS', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'FG003', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks\n\nVehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '128'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': 'Modified Intent to Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '508', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.05% Voclosporin Ophthalmic Solution (VOS): 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'BG001', 'title': '0.10% VOS', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.10% VOS: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'BG002', 'title': '0.20% VOS', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks\n\n0.20% VOS: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'BG003', 'title': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks\n\nVehicle Ophthalmic Solution: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '11.82', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '11.27', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '10.47', 'groupId': 'BG002'}, {'value': '64.1', 'spread': '12.43', 'groupId': 'BG003'}, {'value': '64.1', 'spread': '11.49', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '86'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '84'}, {'value': '65', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '89'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '27', 'upperLimit': '94'}, {'value': '65', 'groupId': 'BG004', 'lowerLimit': '25', 'upperLimit': '94'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '372', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '482', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}, {'value': '389', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-26', 'size': 1165424, 'label': 'Study Protocol: Version 1.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-17T14:24', 'hasProtocol': True}, {'date': '2019-09-04', 'size': 1171049, 'label': 'Study Protocol: Version 2.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-17T14:28', 'hasProtocol': True}, {'date': '2020-06-26', 'size': 1190089, 'label': 'Study Protocol: Version 3.0', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-17T14:29', 'hasProtocol': True}, {'date': '2020-06-26', 'size': 505317, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-17T14:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to one of the following treatment groups:\n\nInvestigational product (IP): one drop 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks, one drop 0.10% VOS OU BID over 12 weeks, or one drop 0.20% VOS OU BID over 12 weeks.\n\nComparator: one drop VOS vehicle OU BID over 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-08', 'studyFirstSubmitDate': '2019-10-30', 'resultsFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-08', 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)', 'timeFrame': '4 Weeks', 'description': 'Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Eye Dryness', 'timeFrame': 'Value at 4 Weeks minus value at baseline', 'description': 'Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry Eye Calcineurin Inhibitors', 'Dry Eye Disease'], 'conditions': ['Dry Eye Syndrome', 'Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.', 'detailedDescription': 'This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.'}, '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* Have a documented history of Dry Eye prior to Visit 1.\n* Willing and able to follow protocol procedures and instructions.\n\nExclusion criteria:\n\n* Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.\n* Recent or current evidence of infection or inflammation in either eye.\n* Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.\n* Have used any investigational drug or device within 30 days prior to Visit 1.\n* Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.\n* Have worn contact lenses 24 hours prior to Visit 1.\n* Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.\n* Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.'}, 'identificationModule': {'nctId': 'NCT04147650', 'acronym': 'AUDREY', 'briefTitle': 'Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aurinia Pharmaceuticals Inc.'}, 'officialTitle': 'A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)', 'orgStudyIdInfo': {'id': 'AUR-VOS-2019-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'interventionNames': ['Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)']}, {'type': 'EXPERIMENTAL', 'label': '0.10% VOS', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'interventionNames': ['Drug: 0.10% VOS']}, {'type': 'EXPERIMENTAL', 'label': '0.20% VOS', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'interventionNames': ['Drug: 0.20% VOS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Ophthalmic Solution', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks', 'interventionNames': ['Drug: Vehicle Ophthalmic Solution']}], 'interventions': [{'name': '0.05% Voclosporin Ophthalmic Solution (VOS)', 'type': 'DRUG', 'description': '0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'armGroupLabels': ['0.05% Voclosporin Ophthalmic Solution (VOS)']}, {'name': '0.10% VOS', 'type': 'DRUG', 'description': '0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'armGroupLabels': ['0.10% VOS']}, {'name': '0.20% VOS', 'type': 'DRUG', 'description': '0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks', 'armGroupLabels': ['0.20% VOS']}, {'name': 'Vehicle Ophthalmic Solution', 'type': 'DRUG', 'description': 'Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks', 'armGroupLabels': ['Vehicle Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '04240', 'city': 'Lewiston', 'state': 'Maine', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 44.10035, 'lon': -70.21478}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '02767', 'city': 'Raynham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 41.94871, 'lon': -71.0731}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Aurinia Investigative Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Mary Palmen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aurinia Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurinia Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}