Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT00534794
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2007-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053090', 'term': 'epinastine'}, {'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': 'clinicaltrialsdisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'PI cannot publish or discuss trial results until written communication is received from Inspire.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Elestat', 'description': '1 drop each eye for 2 days', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pataday', 'description': '1 drop each eye for 1 day', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Ocular Itch Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elestat', 'description': '1 drop each eye for 2 days'}, {'id': 'OG001', 'title': 'Pataday', 'description': '1 drop each eye for 1 day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.532', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'ITT (Intent to Treat)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 hours, 12 hours', 'description': 'Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Comfort Score at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Elestat', 'description': '1 drop each eye for 2 days'}, {'id': 'OG001', 'title': 'Pataday', 'description': '1 drop each eye for 1 day'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.927', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'ITT (Intent to Treat)', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 hours', 'description': 'Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elestat', 'description': '1 drop each eye for 2 days'}, {'id': 'FG001', 'title': 'Pataday', 'description': '1 drop each eye for 1 day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Elestat', 'description': '1 drop each eye for 2 days'}, {'id': 'BG001', 'title': 'Pataday', 'description': '1 drop each eye for 1 day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '12.18', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '13.41', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '12.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2007-09-20', 'resultsFirstSubmitDate': '2009-01-30', 'studyFirstSubmitQcDate': '2007-09-21', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-03', 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Ocular Itch Score From Baseline', 'timeFrame': '0 hours, 12 hours', 'description': 'Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.'}], 'secondaryOutcomes': [{'measure': 'Ocular Comfort Score at 12 Hours', 'timeFrame': '12 hours', 'description': 'Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.'}]}, 'conditionsModule': {'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented history of ocular allergy to cats.\n* Positive skin prick allergen reaction to cat dander.\n\nExclusion Criteria:\n\n* Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.\n* History of severe asthma, reactive airway disease or bronchial obstruction.\n* Ocular surgery or trauma in the last year.'}, 'identificationModule': {'nctId': 'NCT00534794', 'briefTitle': 'Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model', 'orgStudyIdInfo': {'id': '031-408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elestat', 'interventionNames': ['Drug: Elestat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pataday', 'interventionNames': ['Drug: Pataday']}], 'interventions': [{'name': 'Elestat', 'type': 'DRUG', 'description': 'Elestat BID for 2 days', 'armGroupLabels': ['Elestat']}, {'name': 'Pataday', 'type': 'DRUG', 'description': 'Pataday QD for 2 days', 'armGroupLabels': ['Pataday']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael Raizman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Boston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}