Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01743027
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069605', 'term': 'Olopatadine Hydrochloride'}], 'ancestors': [{'id': 'D003990', 'term': 'Dibenzoxepins'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'James Wheeler, Unit Head, Pharma', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected for the duration of the study (6 months). This analysis population includes all participants who were exposed to investigational product for 1-2 instillation(s).', 'description': 'An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained as solicited comments from the study patients and as observations by the study Investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'otherNumAtRisk': 98, 'otherNumAffected': 0, 'seriousNumAtRisk': 98, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'otherNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'otherNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Ocular Itching at Onset of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'title': '3 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.070', 'groupId': 'OG002'}, {'value': '1.91', 'spread': '0.095', 'groupId': 'OG003'}]}]}, {'title': '5 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.075', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '0.076', 'groupId': 'OG002'}, {'value': '1.99', 'spread': '0.103', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '1.82', 'spread': '0.113', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 (3, 5, and 7 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.'}, {'type': 'PRIMARY', 'title': 'Mean Ocular Itching at 24 Hours Duration of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'title': '3 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '1.53', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '2.30', 'spread': '0.132', 'groupId': 'OG003'}]}]}, {'title': '5 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '1.70', 'spread': '0.091', 'groupId': 'OG002'}, {'value': '2.37', 'spread': '0.130', 'groupId': 'OG003'}]}]}, {'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '0.096', 'groupId': 'OG002'}, {'value': '2.14', 'spread': '0.137', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (3, 5, and 7 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Conjunctival Redness at Onset of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '1.96', 'spread': '0.113', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '1.97', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '2.10', 'spread': '0.112', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.66', 'spread': '0.082', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '1.97', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '2.15', 'spread': '0.113', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Conjunctival Redness at 24 Hours Duration of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '0.073', 'groupId': 'OG001'}, {'value': '1.97', 'spread': '0.073', 'groupId': 'OG002'}, {'value': '2.09', 'spread': '0.104', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.04', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '0.073', 'groupId': 'OG001'}, {'value': '2.10', 'spread': '0.073', 'groupId': 'OG002'}, {'value': '2.22', 'spread': '0.104', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '2.08', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.078', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '0.077', 'groupId': 'OG002'}, {'value': '2.23', 'spread': '0.110', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Total Redness at Onset of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '3.92', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '0.240', 'groupId': 'OG001'}, {'value': '4.82', 'spread': '0.243', 'groupId': 'OG002'}, {'value': '5.93', 'spread': '0.330', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '4.80', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '5.73', 'spread': '0.240', 'groupId': 'OG001'}, {'value': '5.85', 'spread': '0.243', 'groupId': 'OG002'}, {'value': '6.50', 'spread': '0.330', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '4.96', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '0.245', 'groupId': 'OG001'}, {'value': '5.88', 'spread': '0.248', 'groupId': 'OG002'}, {'value': '6.67', 'spread': '0.337', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Total Redness at 24 Hours Duration of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'title': '7 minutes post-CAC', 'categories': [{'measurements': [{'value': '5.39', 'spread': '0.214', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '0.213', 'groupId': 'OG001'}, {'value': '5.66', 'spread': '0.212', 'groupId': 'OG002'}, {'value': '6.12', 'spread': '0.302', 'groupId': 'OG003'}]}]}, {'title': '15 minutes post-CAC', 'categories': [{'measurements': [{'value': '5.87', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '0.215', 'groupId': 'OG001'}, {'value': '6.11', 'spread': '0.215', 'groupId': 'OG002'}, {'value': '6.49', 'spread': '0.306', 'groupId': 'OG003'}]}]}, {'title': '20 minutes post-CAC', 'categories': [{'measurements': [{'value': '6.00', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '0.228', 'groupId': 'OG001'}, {'value': '6.02', 'spread': '0.228', 'groupId': 'OG002'}, {'value': '6.49', 'spread': '0.325', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.'}, {'type': 'SECONDARY', 'title': 'Proportion of Ocular Itching Responders at Onset of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '73.7', 'groupId': 'OG001'}, {'value': '59.6', 'groupId': 'OG002'}, {'value': '10.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Itch Responders at 24 Hours Duration of Action', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'OG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}, {'value': '26.3', 'groupId': 'OG002'}, {'value': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'FG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'FG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'FG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '90'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 6 study centers located in the US.', 'preAssignmentDetails': 'Of the 902 enrolled, 557 participants discontinued prior to randomization due to screen failure (390), adverse event (12), lost to follow-up (26), protocol violation (2), withdrawal by patient (85), and other (42). This reporting group includes all randomized participants (345).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '345', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'BG001', 'title': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'BG002', 'title': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'BG003', 'title': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-64 Years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '333', 'groupId': 'BG004'}]}]}, {'title': '≥65 - <75 Years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': '≥75 - <85 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '204', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '141', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 902}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-18', 'studyFirstSubmitDate': '2012-12-04', 'resultsFirstSubmitDate': '2014-07-18', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-18', 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Ocular Itching at Onset of Action', 'timeFrame': 'Day 14 (3, 5, and 7 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.'}, {'measure': 'Mean Ocular Itching at 24 Hours Duration of Action', 'timeFrame': 'Day 1 (3, 5, and 7 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.'}], 'secondaryOutcomes': [{'measure': 'Mean Conjunctival Redness at Onset of Action', 'timeFrame': 'Day 14 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.'}, {'measure': 'Mean Conjunctival Redness at 24 Hours Duration of Action', 'timeFrame': 'Day 1 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.'}, {'measure': 'Mean Total Redness at Onset of Action', 'timeFrame': 'Day 14 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.'}, {'measure': 'Mean Total Redness at 24 Hours Duration of Action', 'timeFrame': 'Day 1 (7, 15, and 20 minutes post-CAC)', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.'}, {'measure': 'Proportion of Ocular Itching Responders at Onset of Action', 'timeFrame': 'Day 14', 'description': 'A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.'}, {'measure': 'Proportion of Itch Responders at 24 Hours Duration of Action', 'timeFrame': 'Day 1', 'description': 'A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic conjunctivitis', 'Olopatadine HCl solution', 'Conjunctival Allergen Challenge', 'Itching eyes', 'Ocular allergies', 'PATADAY', 'PATANOL'], 'conditions': ['Allergic Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '27466061', 'type': 'DERIVED', 'citation': 'Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26.'}, {'pmid': '26266427', 'type': 'DERIVED', 'citation': 'McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.', 'detailedDescription': 'Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.\n* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.\n* Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.\n* History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.\n* Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).\n* Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.\n* Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.\n* Presence of an ocular condition that may affect the study outcomes.\n* History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.\n* Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.\n* History of anaphylactic reaction to any allergens used in this study.\n* Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.\n* Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01743027', 'briefTitle': 'Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model', 'orgStudyIdInfo': {'id': 'C-12-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL-4943A', 'description': 'AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'interventionNames': ['Drug: AL-4943A ophthalmic solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PATADAY', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'interventionNames': ['Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PATANOL', 'description': 'Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'interventionNames': ['Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14', 'interventionNames': ['Drug: AL-4943A ophthalmic solution vehicle']}], 'interventions': [{'name': 'AL-4943A ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['AL-4943A']}, {'name': 'Olopatadine hydrochloride ophthalmic solution, 0.2%', 'type': 'DRUG', 'otherNames': ['PATADAY®'], 'armGroupLabels': ['PATADAY']}, {'name': 'Olopatadine hydrochloride ophthalmic solution, 0.1%', 'type': 'DRUG', 'otherNames': ['PATANOL®'], 'armGroupLabels': ['PATANOL']}, {'name': 'AL-4943A ophthalmic solution vehicle', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Abhijit Narvekar, MS, MBBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}