Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01159769
Status:
COMPLETED
Last Update Posted:
2012-04-03
First Post:
2010-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of 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': 'medinfo@alconlabs.com', 'phone': '800-862-5266', 'title': 'Director of Medical Affairs', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Alcon 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 were collected for the duration of the study: 7 June 2010 to 7 August 2010.', 'description': 'This reporting group includes all subjects who used the study medication at least once (intent to treat). Subjects were queried about any symptoms that would suggest an adverse event with, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"', 'eventGroups': [{'id': 'EG000', 'title': 'Olopatadine 0.2%', 'description': '1 drop self-administered in each eye once daily in the morning for 7 days', 'otherNumAtRisk': 215, 'otherNumAffected': 0, 'seriousNumAtRisk': 215, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Stomach pain', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Colorectal cancer', 'notes': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine 0.2%', 'description': '1 drop self-administered in each eye once daily in the morning for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0', 'description': 'Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who used the study medication at least once (intent to treat).'}, {'type': 'PRIMARY', 'title': 'Overall Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine 0.2%', 'description': '1 drop self-administered in each eye once daily in the morning for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7', 'description': 'Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who used the study medication at least once (intent to treat).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olopatadine 0.2%', 'description': '1 drop self-administered in each eye once daily in the morning for 7 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited from 12 US study centers. Eligible patients having a history of allergic conjunctivitis and treated with protocol-specified anti-allergy medications for at least 7 days within 6 months prior to Visit 1 were enrolled. Investigators reviewed files to identify patients.', 'preAssignmentDetails': '215 patients were enrolled. All patients received the same treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Olopatadine 0.2%', 'description': '1 drop self-administered in each eye once daily in the morning for 7 days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.03', 'spread': '18.58', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2010-07-08', 'resultsFirstSubmitDate': '2012-03-05', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-05', 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Patient Satisfaction', 'timeFrame': 'Day 0', 'description': 'Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."'}, {'measure': 'Overall Patient Satisfaction', 'timeFrame': 'Day 7', 'description': 'Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic conjunctivitis'], 'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 12 years of age or older.\n* History (within the past 24 months) of allergic conjunctivitis.\n* Active signs and symptoms of ocular allergies.\n* Ocular health within normal limits, as determined by the investigator or subinvestigator.\n* Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Contraindications or hypersensitivity to study medication or its components.\n* One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.\n* Known history of recurrent corneal erosion syndrome.\n* Ocular trauma or surgical intervention within 6 months prior to Visit 1.\n* Participation in any other investigational study within 30 days before Visit 1.\n* Pregnant or nursing.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01159769', 'briefTitle': 'Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-10-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olopatadine 0.2%', 'description': '1 drop self-administered in each eye once daily in the morning for 7 days', 'interventionNames': ['Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)']}], 'interventions': [{'name': 'Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)', 'type': 'DRUG', 'otherNames': ['Pataday®'], 'description': 'Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis', 'armGroupLabels': ['Olopatadine 0.2%']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}