Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT01189032
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2010-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@santen.co.jp', 'phone': '+81-6-4802-9341', 'title': 'General Manager of Clinical Development Group', 'organization': 'Santen Pharmaceutical Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo ophthalmic solution', 'otherNumAtRisk': 94, 'otherNumAffected': 17, 'seriousNumAtRisk': 94, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Concentration', 'description': '1% DE-089 ophthalmic solution', 'otherNumAtRisk': 96, 'otherNumAffected': 14, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Concentration', 'description': '3% DE-089 ophthalmic solution', 'otherNumAtRisk': 96, 'otherNumAffected': 28, 'seriousNumAtRisk': 96, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J (8.1)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J (8.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/J (8.1)'}], 'seriousEvents': [{'term': 'Lung adenocarcinoma', 'notes': 'There was a serious adverse event in 3% DE-089 ophthalmic solution group.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA/J (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Fluorescein Staining Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo ophthalmic solution'}, {'id': 'OG001', 'title': 'Low Concentration', 'description': '1% DE-089 ophthalmic solution'}, {'id': 'OG002', 'title': 'High Concentration', 'description': '3% DE-089 ophthalmic solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '-1.55', 'spread': '1.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': "It's the p-value of linear trend. It's adjusted for multiplicity.", 'statisticalMethod': 'maximum contrast method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': "It's the p-value of Saturated at 1% DE-089. It's adjusted for multiplicity.", 'statisticalMethod': 'maximum contrast method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week (discontinued(LOCF))', 'description': 'Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.\n\nThe degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was performed per protocol set (PPS). Excluded cases were 7 subjects (3 subjects in 3% group, 3 subjects in 1% group, and 1 subject in Placebo group).\n\nThe reason of exclusion: used the prohibited concomitant drug, dosing period shortage, number of doses non-compliance, or had no available efficacy data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo ophthalmic solution'}, {'id': 'FG001', 'title': 'Low Concentration', 'description': '1% DE-089 ophthalmic solution'}, {'id': 'FG002', 'title': 'High Concentration', 'description': '3% DE-089 ophthalmic solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '96'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Excluded (n=34)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo ophthalmic solution'}, {'id': 'BG001', 'title': 'Low Concentration', 'description': '1% DE-089 ophthalmic solution'}, {'id': 'BG002', 'title': 'High Concentration', 'description': '3% DE-089 ophthalmic solution'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '17.3', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '56.4', 'spread': '17.8', 'groupId': 'BG002'}, {'value': '56.6', 'spread': '17.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'lastUpdateSubmitDate': '2014-08-08', 'studyFirstSubmitDate': '2010-08-24', 'resultsFirstSubmitDate': '2014-05-23', 'studyFirstSubmitQcDate': '2010-08-24', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-16', 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Fluorescein Staining Score From Baseline', 'timeFrame': 'Baseline and 4-week (discontinued(LOCF))', 'description': 'Fluorescein staining was scored according to the protocol by Shimmura et al. The cornea was divided into 3 equal zones: upper, middle, and lower. Each zone had a staining score ranging between 0 and 3 points, with minimum and maximum total staining scores ranging between 0 and 9 points. 0 is better.\n\nThe degree of staining with Fluorescein dyes was scored as follows: 0 = no staining, 1= staining of less than half of the area, 2= staining of more than half of the area, 3= staining in the whole area.'}]}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those who show:\n\n * Keratoconjunctival disorder confirmed with vital dye staining\n * Abnormal Schirmer score results\n\nExclusion Criteria:\n\n* Eye disease that needs therapy other than that for dry eye\n* Those who need to wear contact lenses during the clinical study'}, 'identificationModule': {'nctId': 'NCT01189032', 'briefTitle': 'Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Dose-Response Study of DE-089 Ophthalmic Solution in Patients With Dry Eye -Late Phase II Confirmatory Study-', 'orgStudyIdInfo': {'id': '00890404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High concentration', 'interventionNames': ['Drug: DE-089 ophthalmic solution']}, {'type': 'EXPERIMENTAL', 'label': 'Low concentration', 'interventionNames': ['Drug: DE-089 ophthalmic solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo ophthalmic solution']}], 'interventions': [{'name': 'DE-089 ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['High concentration']}, {'name': 'DE-089 ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['Low concentration']}, {'name': 'Placebo ophthalmic solution', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Santen study sites', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}}}}