Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-03-11 @ 11:31 AM
Study NCT ID:
NCT03231969
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2017-07-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nfernandez@faes.es', 'phone': '+34 94 481 83 00', 'title': 'Nieves Fernández, MD, PhD', 'organization': 'Faes Farma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety assessment period (Day 1 through Day 22). Adverts events were assessed at all office visits, throughout a period of 22 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Bilastine 0.2%', 'description': 'Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bilastine 0.4%', 'description': 'Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bilastine 0.6%', 'description': 'Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 1, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Bilastine 0%', 'description': 'Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 7, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Corneal Deposits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Macular Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilastine 0.2%', 'description': 'Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'OG001', 'title': 'Bilastine 0.4%', 'description': 'Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'OG002', 'title': 'Bilastine 0.6%', 'description': 'Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'OG003', 'title': 'Bilastine 0% (Vehicle)', 'description': 'Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period'}], 'classes': [{'title': 'Visit 4b: 3 minutes Post-CAC', 'categories': [{'measurements': [{'value': '1.908', 'spread': '0.7809', 'groupId': 'OG000'}, {'value': '1.925', 'spread': '0.9449', 'groupId': 'OG001'}, {'value': '1.177', 'spread': '1.0332', 'groupId': 'OG002'}, {'value': '2.758', 'spread': '0.7146', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4b: 5 minutes Post-CAC', 'categories': [{'measurements': [{'value': '2.075', 'spread': '0.7828', 'groupId': 'OG000'}, {'value': '2.117', 'spread': '0.9531', 'groupId': 'OG001'}, {'value': '1.218', 'spread': '1.1268', 'groupId': 'OG002'}, {'value': '3.017', 'spread': '0.5979', 'groupId': 'OG003'}]}]}, {'title': 'Visit 4b: 7 minutes Post-CAC', 'categories': [{'measurements': [{'value': '2.092', 'spread': '0.7698', 'groupId': 'OG000'}, {'value': '2.100', 'spread': '1.0760', 'groupId': 'OG001'}, {'value': '1.218', 'spread': '1.1157', 'groupId': 'OG002'}, {'value': '2.917', 'spread': '0.5884', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5b: 3 minutes Post-CAC', 'categories': [{'measurements': [{'value': '1.397', 'spread': '1.1050', 'groupId': 'OG000'}, {'value': '1.250', 'spread': '0.8872', 'groupId': 'OG001'}, {'value': '0.708', 'spread': '0.8908', 'groupId': 'OG002'}, {'value': '2.558', 'spread': '0.8032', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5b: 5 minutes Post-CAC', 'categories': [{'measurements': [{'value': '1.466', 'spread': '0.9300', 'groupId': 'OG000'}, {'value': '1.464', 'spread': '0.9592', 'groupId': 'OG001'}, {'value': '0.817', 'spread': '1.0503', 'groupId': 'OG002'}, {'value': '2.642', 'spread': '0.7505', 'groupId': 'OG003'}]}]}, {'title': 'Visit 5b: 7 minutes Post-CAC', 'categories': [{'measurements': [{'value': '1.379', 'spread': '0.8573', 'groupId': 'OG000'}, {'value': '1.518', 'spread': '1.0340', 'groupId': 'OG001'}, {'value': '0.742', 'spread': '0.9837', 'groupId': 'OG002'}, {'value': '2.642', 'spread': '0.7704', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6: 3 minutes Post-CAC', 'categories': [{'measurements': [{'value': '0.679', 'spread': '0.6662', 'groupId': 'OG000'}, {'value': '0.732', 'spread': '0.9127', 'groupId': 'OG001'}, {'value': '0.392', 'spread': '0.5749', 'groupId': 'OG002'}, {'value': '2.542', 'spread': '0.8384', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6: 5 minutes Post-CAC', 'categories': [{'measurements': [{'value': '0.920', 'spread': '0.7235', 'groupId': 'OG000'}, {'value': '1.143', 'spread': '0.9987', 'groupId': 'OG001'}, {'value': '0.558', 'spread': '0.6355', 'groupId': 'OG002'}, {'value': '2.592', 'spread': '0.8343', 'groupId': 'OG003'}]}]}, {'title': 'Visit 6: 7 minutes Post-CAC', 'categories': [{'measurements': [{'value': '1.000', 'spread': '0.7454', 'groupId': 'OG000'}, {'value': '1.214', 'spread': '0.9421', 'groupId': 'OG001'}, {'value': '0.583', 'spread': '0.6706', 'groupId': 'OG002'}, {'value': '2.483', 'spread': '0.9024', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.791', 'ciLowerLimit': '-1.203', 'ciUpperLimit': '-0.378', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.851', 'ciLowerLimit': '-1.263', 'ciUpperLimit': '-0.439', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.545', 'ciLowerLimit': '-1.954', 'ciUpperLimit': '-1.135', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.208', 'ciLowerLimit': '-1.639', 'ciUpperLimit': '-0.778', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.245', 'ciLowerLimit': '-1.679', 'ciUpperLimit': '-0.811', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.846', 'ciLowerLimit': '-2.273', 'ciUpperLimit': '-1.418', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.696', 'ciLowerLimit': '-2.080', 'ciUpperLimit': '-1.312', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.617', 'ciLowerLimit': '-2.001', 'ciUpperLimit': '-1.232', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.009', 'ciLowerLimit': '-2.387', 'ciUpperLimit': '-1.630', 'groupDescription': 'Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).', 'description': 'The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bilastine 0.2%', 'description': 'Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'FG001', 'title': 'Bilastine 0.4%', 'description': 'Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'FG002', 'title': 'Bilastine 0.6%', 'description': 'Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'FG003', 'title': 'Bilastine 0%', 'description': 'Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Bilastine 0.2%', 'description': 'Bilastine 0.2%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'BG001', 'title': 'Bilastine 0.4%', 'description': 'Bilastine 0.4%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'BG002', 'title': 'Bilastine 0.6%', 'description': 'Bilastine 0.6%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'BG003', 'title': 'Bilastine 0%', 'description': 'Bilastine 0%: 1 drop in each eye at 3 separate times during a 25 day period.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '47.0', 'spread': '13.95', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '13.4', 'groupId': 'BG002'}, {'value': '48.3', 'spread': '13.24', 'groupId': 'BG003'}, {'value': '49.4', 'spread': '12.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '102', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ocular Itching- Baseline', 'classes': [{'title': 'Visit 4b: Pre- CAC', 'categories': [{'measurements': [{'value': '0.058', 'spread': '0.2043', 'groupId': 'BG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'BG001'}, {'value': '0.048', 'spread': '0.1981', 'groupId': 'BG002'}, {'value': '0.025', 'spread': '0.1006', 'groupId': 'BG003'}, {'value': '0.03275', 'spread': '0.12575', 'groupId': 'BG004'}]}]}, {'title': 'Visit 5b: Pre- CAC', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'BG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'BG001'}, {'value': '0.033', 'spread': '0.1826', 'groupId': 'BG002'}, {'value': '0.033', 'spread': '0.1826', 'groupId': 'BG003'}, {'value': '0.0165', 'spread': '0.0913', 'groupId': 'BG004'}]}]}, {'title': 'Visit 6: Pre- CAC', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'BG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'BG001'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'BG002'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'BG003'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The primary efficacy measure was ocular itching evaluated by the subject post-CAC at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment), using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.The baseline measures for this primary outcome will be the "pre-CAC" values (pre-Conjunctival Allergen Challenge).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-28', 'size': 998295, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-15T03:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2018-10-25', 'completionDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2017-07-20', 'dispFirstSubmitQcDate': '2021-10-28', 'resultsFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2017-07-26', 'dispFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-28', 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching', 'timeFrame': 'The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).', 'description': 'The primary efficacy measure was ocular itching evaluated by the subject post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* be at least 18 years old\n* be willing and able to avoid all disallowed medications and contact lenses\n* must have a pregnancy test if of childbearing potential\n* must be able to read an eye chart from 10 feet away\n\nKey Exclusion Criteria:\n\n* must not have any allergies to the study medications\n* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters\n* must not have used immunotherapy in the last 2 years\n* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial'}, 'identificationModule': {'nctId': 'NCT03231969', 'briefTitle': 'A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'Faes Farma, S.A.'}, 'officialTitle': 'A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model', 'orgStudyIdInfo': {'id': 'BOFT-0117/DR-CAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilastine 0.2%', 'description': 'Bilastine Ophthalmic solution 0.2%\n\n1 drop in each eye at 3 separate times during a 25 day period.', 'interventionNames': ['Drug: Bilastine 0.2%']}, {'type': 'EXPERIMENTAL', 'label': 'Bilastine 0.4%', 'description': 'Bilastine Ophthalmic solution 0.4%\n\n1 drop in each eye at 3 separate times during a 25 day period.', 'interventionNames': ['Drug: Bilastine 0.4%']}, {'type': 'EXPERIMENTAL', 'label': 'Bilastine 0.6%', 'description': 'Bilastine Ophthalmic solution 0.6%\n\n1 drop in each eye at 3 separate times during a 25 day period.', 'interventionNames': ['Drug: Bilastine 0.6%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Bilastine 0%', 'description': 'Vehicle of Bilastine Ophthalmic Solution\n\n1 drop in each eye at 3 separate times during a 25 day period.', 'interventionNames': ['Drug: Bilastine 0%']}], 'interventions': [{'name': 'Bilastine 0.2%', 'type': 'DRUG', 'description': '1 drop in each eye at 3 separate times during a 25 day period.', 'armGroupLabels': ['Bilastine 0.2%']}, {'name': 'Bilastine 0.4%', 'type': 'DRUG', 'description': '1 drop in each eye at 3 separate times during a 25 day period.', 'armGroupLabels': ['Bilastine 0.4%']}, {'name': 'Bilastine 0.6%', 'type': 'DRUG', 'description': '1 drop in each eye at 3 separate times during a 25 day period.', 'armGroupLabels': ['Bilastine 0.6%']}, {'name': 'Bilastine 0%', 'type': 'DRUG', 'description': '1 drop in each eye at 3 separate times during a 25 day period.', 'armGroupLabels': ['Bilastine 0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ora Clinical Research Center', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faes Farma, S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}