Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:50 PM
Study NCT ID:
NCT01435460
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2011-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069559', 'term': 'Loteprednol Etabonate'}, {'id': 'D000069605', 'term': 'Olopatadine Hydrochloride'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'tuyen.ong@bausch.com', 'phone': '(973) 360-6389', 'title': 'Tuyen Ong', 'organization': 'Bausch & Lomb, Incorporated'}, 'certainAgreement': {'otherDetails': 'All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 days', 'eventGroups': [{'id': 'EG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%', 'otherNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Deviated Septum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bulbar Conjunctival Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%'}, {'id': 'OG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.521', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '0.585', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to day 15 (visit 3)', 'description': 'Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed from the per protocol (PP) population'}, {'type': 'PRIMARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%'}, {'id': 'OG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.74', 'spread': '0.469', 'groupId': 'OG000'}, {'value': '-3.28', 'spread': '0.908', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to day 15 (visit 3)', 'description': 'Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed from the per protocol (PP) population'}, {'type': 'SECONDARY', 'title': 'Bulbar Conjunctival Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%'}, {'id': 'OG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.569', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '0.610', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to day 8 (visit 2)', 'description': 'Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed from the per protocol (PP) population'}, {'type': 'SECONDARY', 'title': 'Ocular Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%'}, {'id': 'OG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.46', 'spread': '0.876', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '0.851', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to day 8 (visit 2)', 'description': 'Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed from the per protocol (PP) population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%'}, {'id': 'FG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Three hundred participants were enrolled in the study. First participant was enrolled 08/03/2010, last participant exited on 04/26/2011. This study was conducted at 7 sites in China.', 'preAssignmentDetails': 'Three hundred participants were randomized into two groups, 151 to be treated with Alrex and 149 to be treated with Patanol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%'}, {'id': 'BG001', 'title': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '14.01', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '12.85', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '13.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-17', 'studyFirstSubmitDate': '2011-09-14', 'resultsFirstSubmitDate': '2012-02-17', 'studyFirstSubmitQcDate': '2011-09-15', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-17', 'studyFirstPostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bulbar Conjunctival Injection', 'timeFrame': 'Change from baseline to day 15 (visit 3)', 'description': 'Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe'}, {'measure': 'Ocular Itching', 'timeFrame': 'Change from baseline to day 15 (visit 3)', 'description': 'Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe'}], 'secondaryOutcomes': [{'measure': 'Bulbar Conjunctival Injection', 'timeFrame': 'Change from baseline to day 8 (visit 2)', 'description': 'Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe'}, {'measure': 'Ocular Itching', 'timeFrame': 'Change from baseline to day 8 (visit 2)', 'description': 'Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ocular allergy'], 'conditions': ['Seasonal Allergic Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '22627057', 'type': 'DERIVED', 'citation': 'Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.\n\nExclusion Criteria:\n\n* Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.\n* Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.\n* Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.\n* Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters."}, 'identificationModule': {'nctId': 'NCT01435460', 'briefTitle': 'Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)', 'orgStudyIdInfo': {'id': '634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alrex', 'description': 'Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%', 'interventionNames': ['Drug: Loteprednol etabonate 0.2%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patanol', 'description': 'Ophthalmic solution containing olopatadine, 0.1%', 'interventionNames': ['Drug: Olopatadine 0.1%']}], 'interventions': [{'name': 'Loteprednol etabonate 0.2%', 'type': 'DRUG', 'otherNames': ['Alrex'], 'description': '1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.', 'armGroupLabels': ['Alrex']}, {'name': 'Olopatadine 0.1%', 'type': 'DRUG', 'otherNames': ['Patanol'], 'description': '1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.', 'armGroupLabels': ['Patanol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '556741', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Bausch & Lomb Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Esther Chu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}