Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-10 @ 10:37 AM
Study NCT ID:
NCT01754766
Status:
COMPLETED
Last Update Posted:
2014-02-04
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AGN-229666 for the Treatment of Allergic Conjunctivitis
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': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.', 'otherNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Itching Score at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.'}, {'id': 'OG002', 'title': 'Vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.500', 'spread': '0.5123', 'groupId': 'OG000'}, {'value': '0.319', 'spread': '0.3947', 'groupId': 'OG001'}, {'value': '1.867', 'spread': '0.9485', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point'}, {'type': 'SECONDARY', 'title': 'Ocular Itching Score at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.'}, {'id': 'OG002', 'title': 'Vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.358', 'spread': '0.4083', 'groupId': 'OG000'}, {'value': '0.214', 'spread': '0.3582', 'groupId': 'OG001'}, {'value': '1.258', 'spread': '0.9249', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15', 'description': 'The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point'}, {'type': 'SECONDARY', 'title': 'Conjunctival Hyperemia Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.'}, {'id': 'OG001', 'title': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.'}, {'id': 'OG002', 'title': 'Vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.387', 'spread': '0.6118', 'groupId': 'OG000'}, {'value': '1.345', 'spread': '1.0531', 'groupId': 'OG001'}, {'value': '1.633', 'spread': '0.5972', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.'}, {'id': 'FG001', 'title': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.'}, {'id': 'FG002', 'title': 'Vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.'}, {'id': 'BG001', 'title': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.'}, {'id': 'BG002', 'title': 'Vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-30 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': '>30-40 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': '>40 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2012-12-19', 'resultsFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Itching Score at Day 1', 'timeFrame': 'Day 1', 'description': 'The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.'}], 'secondaryOutcomes': [{'measure': 'Ocular Itching Score at Day 15', 'timeFrame': 'Day 15', 'description': 'The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.'}, {'measure': 'Conjunctival Hyperemia Score', 'timeFrame': 'Day 1', 'description': 'Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of AGN-229666 for the treatment of allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese patients living in Japan with a history of allergic conjunctivitis\n* Willing to discontinue wearing contact lenses during the study period\n\nExclusion Criteria:\n\n* Use of nicotine products during the study period\n* Presence of active eye infection (bacterial, viral, or fungal)\n* History of an ocular herpetic infection\n* Eye surgery intervention within 3 months and/or a history of refractive surgery within the past 6 months'}, 'identificationModule': {'nctId': 'NCT01754766', 'briefTitle': 'AGN-229666 for the Treatment of Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '229666-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGN-229666 Dose A', 'description': 'One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.', 'interventionNames': ['Drug: AGN-229666']}, {'type': 'EXPERIMENTAL', 'label': 'AGN-229666 Dose B', 'description': 'One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.', 'interventionNames': ['Drug: AGN-229666']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'vehicle of AGN-229666', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.', 'interventionNames': ['Other: vehicle of AGN-229666']}], 'interventions': [{'name': 'AGN-229666', 'type': 'DRUG', 'description': 'One drop of AGN-229666 into each eye on Day 1 and Day 15.', 'armGroupLabels': ['AGN-229666 Dose A', 'AGN-229666 Dose B']}, {'name': 'vehicle of AGN-229666', 'type': 'OTHER', 'description': 'One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.', 'armGroupLabels': ['vehicle of AGN-229666']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}