Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-09 @ 3:31 AM
Study NCT ID:
NCT00818805
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2009-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}, {'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'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'}, {'id': 'C012293', 'term': 'tranilast'}], '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': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Labs'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Technical problems with measurement leading to unreliable or uninterpretable data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Olopatadine 0.1% One Eye', 'description': 'Olopatadine 0.1% in one eye in either the first or second period', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tranilast 0.5% One Eye', 'description': 'Tranilast 0.5% in one eye in either the first or second period', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (Olopatadine) One Eye', 'description': 'Placebo (Olopatadine) in one eye in either the first or second period', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo (Tranilast) One Eye', 'description': 'Placebo (Tranilast) in one eye in either the first or second period', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Olopatadine 0.1% One Eye', 'description': 'Olopatadine 0.1% in one eye in either the first or second period'}, {'id': 'OG001', 'title': 'Tranilast 0.5% One Eye', 'description': 'Tranilast 0.5% in one eye in either the first or second period'}, {'id': 'OG002', 'title': 'Placebo (Olopatadine)', 'description': 'Placebo (Olopatadine) in one eye in either the first or second period'}, {'id': 'OG003', 'title': 'Placebo (Tranilast)', 'description': 'Placebo (Tranilast) in one eye in either the first or second period'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '0.08', 'spread': '0.44', 'groupId': 'OG003'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '0.28', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '0.56', 'spread': '0.69', 'groupId': 'OG003'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '0.67', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '0.61', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': '75 minutes', 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '0.78', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '0.94', 'spread': '0.75', 'groupId': 'OG003'}]}]}, {'title': '105 minutes', 'categories': [{'measurements': [{'value': '0.94', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.70', 'groupId': 'OG002'}, {'value': '0.97', 'spread': '0.81', 'groupId': 'OG003'}]}]}, {'title': '120 minutes', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '1.08', 'spread': '0.81', 'groupId': 'OG003'}]}]}, {'title': '135 minutes', 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.33', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '1.19', 'spread': '0.82', 'groupId': 'OG003'}]}]}, {'title': '150 minutes', 'categories': [{'measurements': [{'value': '1.25', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '1.36', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '1.25', 'spread': '0.77', 'groupId': 'OG003'}]}]}, {'title': '165 minutes', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '1.39', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '1.33', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': '180 minutes', 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '1.47', 'spread': '0.88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-180 minutes after entering the examination room', 'description': 'Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Score in Ocular Symptom Questionnaire', 'timeFrame': '15-180 min.', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olopatadine 0.1% First, Then Tranilast Second', 'description': 'Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next'}, {'id': 'FG001', 'title': 'Tranilast 0.5% First, Then Olopatadine Second', 'description': 'Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The recruitment period: May 21-31, 2008 Location: Samoncho Clinic', 'preAssignmentDetails': 'The study was conducted using an Ohio chamber in two parts: 1) a proof-of concept pilot study designed to assess the appropriateness of the OHIO chamber to induce ocular symptoms. 2) a randomized, single-masked, placebo-controlled, cross-over study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2012-05-29', 'studyFirstSubmitDate': '2009-01-07', 'resultsFirstSubmitDate': '2009-12-03', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-11', 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire', 'timeFrame': '0-180 minutes after entering the examination room', 'description': 'Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.'}], 'secondaryOutcomes': [{'measure': 'Change in Total Score in Ocular Symptom Questionnaire', 'timeFrame': '15-180 min.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['conjunctivitis'], 'conditions': ['Allergic Conjunctivitis']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age/Gender: males and females aged \\>20 to \\< 65 years (at the time of obtaining consent).\n2. Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years.\n3. Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it.\n4. Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.\n\nExclusion Criteria:\n\n1. Cases with an ocular disease that requires treatment other than allergic conjunctivitis.\n2. Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation.\n3. Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis.\n4. Cases with past history of anaphylaxis.\n5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast.\n6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy).\n7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period.\n8. Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.'}, 'identificationModule': {'nctId': 'NCT00818805', 'briefTitle': 'Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'AL-292ET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olopatadine 0.1% one eye', 'description': 'Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye', 'interventionNames': ['Drug: Olopatadine 0.1%']}, {'type': 'EXPERIMENTAL', 'label': 'Tranilast 0.5% one eye', 'description': 'Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye', 'interventionNames': ['Drug: Tranilast 0.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Olopatadine)', 'description': 'Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye', 'interventionNames': ['Drug: Placebo (Olopatadine)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Tranilast)', 'description': 'Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye', 'interventionNames': ['Drug: Placebo (Tranilast)']}], 'interventions': [{'name': 'Olopatadine 0.1%', 'type': 'DRUG', 'description': 'one drop in one eye', 'armGroupLabels': ['Olopatadine 0.1% one eye']}, {'name': 'Tranilast 0.5%', 'type': 'DRUG', 'description': 'one drop in one eye', 'armGroupLabels': ['Tranilast 0.5% one eye']}, {'name': 'Placebo (Olopatadine)', 'type': 'DRUG', 'description': 'one drop in contralateral eye', 'armGroupLabels': ['Placebo (Olopatadine)']}, {'name': 'Placebo (Tranilast)', 'type': 'DRUG', 'description': 'one drop in contralateral eye', 'armGroupLabels': ['Placebo (Tranilast)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}