Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01551056
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'bergamini@nicox.com', 'phone': '817-529-9315', 'title': 'Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President', 'organization': 'Nicox Ophthalmics Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected through the duration of the study, over the course of approximately 3 months. All subjects who received study medication were evaluable for the safety analysis.', 'description': 'Throughout the visits, staff collected all Adverse Events reported, elicited or observed.', 'eventGroups': [{'id': 'EG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period', 'otherNumAtRisk': 46, 'otherNumAffected': 1, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period', 'otherNumAtRisk': 45, 'otherNumAffected': 5, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '3 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.71', 'spread': '0.886', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '0.720', 'groupId': 'OG001'}]}]}, {'title': '5 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.910', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '0.644', 'groupId': 'OG001'}]}]}, {'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.76', 'spread': '0.944', 'groupId': 'OG000'}, {'value': '2.22', 'spread': '0.875', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 5, 7 minutes post-CAC', 'description': 'A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'PRIMARY', 'title': 'Ocular Itching at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '3 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.638', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.979', 'groupId': 'OG001'}]}]}, {'title': '5 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.691', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.980', 'groupId': 'OG001'}]}]}, {'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.783', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.998', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3, 5, 7 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'PRIMARY', 'title': 'Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.771', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.796', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.96', 'spread': '0.777', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.788', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.780', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.759', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'PRIMARY', 'title': 'Conjunctival Redness at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.02', 'spread': '0.728', 'groupId': 'OG000'}, {'value': '2.05', 'spread': '0.714', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.23', 'spread': '0.667', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.736', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.28', 'spread': '0.644', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.762', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.786', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.832', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.825', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.756', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.821', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.771', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Ciliary Redness at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.64', 'spread': '0.810', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.645', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.789', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '0.769', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.95', 'spread': '0.806', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '0.767', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.719', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '0.798', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.781', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.775', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.768', 'groupId': 'OG000'}, {'value': '2.03', 'spread': '0.764', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Episcleral Redness at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.804', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.725', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.10', 'spread': '0.791', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.793', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.20', 'spread': '0.758', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '0.778', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.461', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '0.550', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.605', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.693', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.605', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.802', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Chemosis at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.501', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.702', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.12', 'spread': '0.685', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.895', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.736', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.950', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Eyelid Swelling at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Tearing at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Rhinorrhea at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Nasal Pruritis at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Nasal Congestion at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}, {'value': '93.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.', 'unitOfMeasure': '%participants with at least 1 nasal symp', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '82.2', 'groupId': 'OG001'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000'}, {'value': '84.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.', 'unitOfMeasure': '%participants with at least 1 nasal symp', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) with observed data only.'}, {'type': 'SECONDARY', 'title': 'Tolerability of Study Medication at Visit 3A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'OG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'classes': [{'title': 'Upon instillation', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': '1 minute post-instillation', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': '2 minutes post-instillation', 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'upon instillation, 1 minute and 2 minutes post instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'FG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from three sites in the US.', 'preAssignmentDetails': 'There were 91 subjects enrolled, 2 subjects discontinued, and 89 subjects completed the study. Participant flow and baseline characteristics are presented for the 91 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AC-170 0.24%', 'description': 'AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'BG001', 'title': 'AC-170 0%', 'description': 'AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '14.95', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '14.08', 'groupId': 'BG001'}, {'value': '37.4', 'spread': '14.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', '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': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2015-04-30', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-06', 'studyFirstSubmitDate': '2012-03-08', 'dispFirstSubmitQcDate': '2015-04-30', 'resultsFirstSubmitDate': '2017-06-27', 'studyFirstSubmitQcDate': '2012-03-08', 'dispFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-06', 'studyFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '3, 5, 7 minutes post-CAC', 'description': 'A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.'}, {'measure': 'Ocular Itching at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '3, 5, 7 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.'}, {'measure': 'Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.'}, {'measure': 'Conjunctival Redness at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.'}], 'secondaryOutcomes': [{'measure': 'Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.'}, {'measure': 'Ciliary Redness at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.'}, {'measure': 'Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.'}, {'measure': 'Episcleral Redness at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.'}, {'measure': 'Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.'}, {'measure': 'Chemosis at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.'}, {'measure': 'Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.'}, {'measure': 'Eyelid Swelling at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.'}, {'measure': 'Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.'}, {'measure': 'Tearing at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.'}, {'measure': 'Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.'}, {'measure': 'Rhinorrhea at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.'}, {'measure': 'Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.'}, {'measure': 'Nasal Pruritis at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.'}, {'measure': 'Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.'}, {'measure': 'Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.'}, {'measure': 'Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.'}, {'measure': 'Nasal Congestion at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.'}, {'measure': 'Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.'}, {'measure': 'Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)', 'timeFrame': '7, 15, 20 minutes post-CAC', 'description': 'A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.'}, {'measure': 'Tolerability of Study Medication at Visit 3A', 'timeFrame': 'upon instillation, 1 minute and 2 minutes post instillation', 'description': 'Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* positive bilateral conjunctival allergen challenge (CAC) reaction\n\nExclusion Criteria:\n\n* known contraindications or sensitivities to the study medication or its components\n* any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters\n* use of disallowed medication during the period indicated prior to the enrollment or during the study'}, 'identificationModule': {'nctId': 'NCT01551056', 'briefTitle': 'A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aciex Therapeutics, Inc.'}, 'officialTitle': 'A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis', 'orgStudyIdInfo': {'id': '11-100-0012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AC-170 0.24%', 'interventionNames': ['Drug: AC-170 0.24%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'AC-170 0%', 'interventionNames': ['Drug: AC-170 0%']}], 'interventions': [{'name': 'AC-170 0.24%', 'type': 'DRUG', 'description': '1 drop in each eye at 2 separate times during a 14 day period', 'armGroupLabels': ['AC-170 0.24%']}, {'name': 'AC-170 0%', 'type': 'DRUG', 'description': '1 drop in each eye at 2 separate times during a 14 day period', 'armGroupLabels': ['AC-170 0%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ora, Inc.', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}], 'overallOfficials': [{'name': 'Jack Greiner, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles River Eye Associates'}, {'name': 'Gail Torkildsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andover Eye Associates'}, {'name': 'Stacey Ackerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philadelphia Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aciex Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}