Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-11 @ 12:27 PM
Study NCT ID:
NCT03088605
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of TOP1630 for Dry Eye Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}}}, '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@topivert.com', 'phone': '+44 203 763 9469', 'title': 'Director of Clinical Trials', 'organization': 'Topivert Pharma Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 6, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 4, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ocular itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Instillation site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Instillation site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.156', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.1163', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.1242', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Visual Acuity will be measured using the EDTRS chart to assess changes from baseline', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed represents the sum of numbers analyzed Part 1 and Part 2'}, {'type': 'PRIMARY', 'title': 'Slit-lamp Biomicroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Drop Comfort Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.846', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.495', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame', 'description': 'The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '2.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'a non-contact tonometer will be used to perform IOP to assess changes from baseline.', 'unitOfMeasure': 'unit of measure "mmHg"', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed comes from Part 1 and Part 2'}, {'type': 'PRIMARY', 'title': 'Corneal Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '59.4', 'spread': '1.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6', 'unitOfMeasure': 'unit of measure "mm"', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed comes from Part 2'}, {'type': 'PRIMARY', 'title': 'Undilated Fundoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vital Signs - Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '4.24', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.8', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '15.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed comes from Part 1 and Part 2'}, {'type': 'PRIMARY', 'title': 'Vital Signs - O2 Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.8', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '97.0', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.3', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '95.7', 'spread': '1.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline', 'unitOfMeasure': 'percentage of 02 saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed comes from Part 1 and Part 2'}, {'type': 'PRIMARY', 'title': 'Vital Signs - Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '128.0', 'spread': '29.32', 'groupId': 'OG000'}, {'value': '148.5', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.9', 'spread': '15.97', 'groupId': 'OG000'}, {'value': '128.2', 'spread': '17.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed comes from Part 1 and Part 2'}, {'type': 'PRIMARY', 'title': 'Vital Signs - Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '89.5', 'spread': '9.19', 'groupId': 'OG001'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.2', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '72.0', 'spread': '9.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed comes from Part 1 and Part 2'}, {'type': 'SECONDARY', 'title': 'Ocular Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0', 'groupDescription': 'Change from Baseline. ANCOVA model includes baseline scores as a covariate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dry Eye Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.5', 'groupDescription': 'Change form baseline. ANCOVA model includes baseline score as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dry Eye Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '5.88', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '6.60', 'spread': '2.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.42', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '-0.47', 'groupDescription': 'Change from baseline. ANCOVA model includes baseline score as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tear Film Break up Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1.629', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.480', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.199', 'ciLowerLimit': '-0.177', 'ciUpperLimit': '0.575', 'groupDescription': 'Change from Baseline; ANCOVA model includes baseline score as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Schirmer's Test", 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '4.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.0', 'groupDescription': 'Change from baseline. ANCOVA model includes baseline score as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Measurement of Schirmer test strips (mm length of moistened area after 5 minutes)', 'unitOfMeasure': 'mm in 5 minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '0.832', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '0.648', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.23', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.03', 'groupDescription': 'Change from baseline. ANCOVA model includes baseline score as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed daily between visit 3b (day 27) to visit 4b (day 35)', 'description': 'Daily symptom assessment using diary cards - outcome for worst symptom, ie symptom with highest severity score at baseline for each patient; calculated using the daily average between visit 3b to visit 4b Ora Calibra Ocular Discomfort \\& 4-Symptom Questionnaire (0-5 scale where 0 = none and 5 = worst)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active', 'description': 'TOP1630 Ophthalmic Solution\n\nTOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution\n\nPlacebo to TOP1630 Ophthalmic Solution: Bilateral ocular drug administration'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '11.42', 'groupId': 'BG000'}, {'value': '65.3', 'spread': '11.92', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '11.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], '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': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-20', 'size': 3690997, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-09T16:08', 'hasProtocol': True}, {'date': '2017-05-15', 'size': 875612, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-21T11:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'dispFirstSubmitDate': '2018-09-21', 'completionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2017-03-10', 'resultsFirstSubmitDate': '2020-01-21', 'studyFirstSubmitQcDate': '2017-03-16', 'dispFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-22', 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Visual Acuity will be measured using the EDTRS chart to assess changes from baseline'}, {'measure': 'Slit-lamp Biomicroscopy', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Slit lamp biomicroscopy exams will be performed to assess any changes from baseline; outcome measure is number of patients with no abnormalities'}, {'measure': 'Drop Comfort Assessment', 'timeFrame': 'Part 1: 12 days time frame', 'description': 'The comfort of the eye drop will be performed to assess changes from baseline. Drop Comfort Assessment Scale; 0-10; 0 being very comfortable and 10 being very uncomfortable'}, {'measure': 'Intraocular Pressure', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'a non-contact tonometer will be used to perform IOP to assess changes from baseline.'}, {'measure': 'Corneal Sensitivity', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline. Corneal Sensitivity Scale. Scale of 0-6'}, {'measure': 'Undilated Fundoscopy', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline; outcome measure is number of patients with no abnormalities'}, {'measure': 'Vital Signs - Pulse', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline'}, {'measure': 'Vital Signs - O2 Saturation', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline'}, {'measure': 'Vital Signs - Systolic Blood Pressure', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline'}, {'measure': 'Vital Signs - Diastolic Blood Pressure', 'timeFrame': 'Part 1: 12 days time frame; Part 2: 35 days time frame', 'description': 'Changes in vital signs is performed to assess changes from baseline'}], 'secondaryOutcomes': [{'measure': 'Ocular Discomfort', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Ocular discomfort Scale severity assessment (0-4 scale where 0 = none and 4 = constant)'}, {'measure': 'Dry Eye Symptoms', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Dry eye syndrome symptom assessment Scale (grittiness) (0-5 scale where 0 = none and 5 = worst)'}, {'measure': 'Dry Eye Signs', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Dry eye syndrome staining Score assessments (total lissamine green staining score, 0-20 where 0 = no staining)'}, {'measure': 'Tear Film Break up Time', 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Tear film break up time measured (in seconds) after instillation of sodium fluorescein solution'}, {'measure': "Schirmer's Test", 'timeFrame': 'Part 2: 35 days time frame', 'description': 'Measurement of Schirmer test strips (mm length of moistened area after 5 minutes)'}, {'measure': 'Daily Symptom Assessment', 'timeFrame': 'Assessed daily between visit 3b (day 27) to visit 4b (day 35)', 'description': 'Daily symptom assessment using diary cards - outcome for worst symptom, ie symptom with highest severity score at baseline for each patient; calculated using the daily average between visit 3b to visit 4b Ora Calibra Ocular Discomfort \\& 4-Symptom Questionnaire (0-5 scale where 0 = none and 5 = worst)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'In subjects with Dry Eye Syndrome:\n\nThe primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.\n\nThe secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.', 'detailedDescription': 'This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.\n\nEligible subjects will be randomized double masked to either TOP1630 or placebo.\n\nPart 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.\n\nPart 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy'}, '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 reported history of dry eye;\n* Have a history of use of eye drops for dry eye symptoms;\n\nAdditionally for Part 2\n\nSymptoms of dry eye syndrome including:\n\n* Ocular discomfort\n* Conjunctival redness\n* Tear film break up time\n* Schirmer test score\n\nSigns of dry eye syndrome including:\n\nConjunctival staining score\n\nExclusion Criteria:\n\n* Have any clinically significant slit lamp findings at entry visit ;\n* Be diagnosed with an ongoing ocular infection;\n* Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;\n* Have any planned ocular and/or lid surgeries 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 test article 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;"}, 'identificationModule': {'nctId': 'NCT03088605', 'briefTitle': 'Safety and Efficacy of TOP1630 for Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'ORA, Inc.'}, 'officialTitle': 'A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'TOP1630-TV-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'TOP1630 Ophthalmic Solution', 'interventionNames': ['Drug: TOP1630 Ophthalmic Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (Vehicle) Ophthalmic Solution', 'interventionNames': ['Drug: Placebo to TOP1630 Ophthalmic Solution']}], 'interventions': [{'name': 'TOP1630 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Bilateral ocular drug administration', 'armGroupLabels': ['Active']}, {'name': 'Placebo to TOP1630 Ophthalmic Solution', 'type': 'DRUG', 'description': 'Bilateral ocular drug administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'G Torkildsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ORA, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Topivert Pharma Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}