Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT02023268
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2013-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
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': 'p.pouliquen@laboratoires-thea.fr', 'phone': '04 73 98 14 36', 'title': 'Dr Pascale Pouliquen', 'organization': 'Laboratoires Théa'}, 'certainAgreement': {'otherDetails': 'All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever from without prior written agreement of THEA', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'T2762', 'description': 'T2762: 1 drop in each eye 3 to 6 times daily during 84 days', 'otherNumAtRisk': 52, 'otherNumAffected': 0, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vismed®', 'description': 'Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days', 'otherNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Ocular Staining (With Oxford Scale - Ranges : 0-15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T2762', 'description': 'T2762: drop in each eye 3 to 6 times daily during 84 days'}, {'id': 'OG001', 'title': 'Vismed', 'description': 'Vismed : 1 drop in each eye 3 to 6 times daily during 84 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 35', 'description': 'Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)\n\nGlobal Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 patients with major protocol deviations were excluded of the analysed population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2762', 'description': 'T2762: 1 drop in each eye 3 to 6 times daily during 84 days'}, {'id': 'FG001', 'title': 'Vismed®', 'description': 'Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T2762', 'description': 'T2762: 1 drop in each eye 3 to 6 times daily during 84 days'}, {'id': 'BG001', 'title': 'Vismed®', 'description': 'Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '59.2', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Tunisia', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', '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': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2013-12-23', 'resultsFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2013-12-23', 'lastUpdatePostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-08', 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Ocular Staining (With Oxford Scale - Ranges : 0-15)', 'timeFrame': 'Baseline and Day 35', 'description': 'Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)\n\nGlobal Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent\n* Male or female aged from ≥ 18 years old.\n* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.\n\nExclusion Criteria:\n\n* Best far corrected visual acuity \\< 1/10\n* Severe blepharitis\n* Severe Dry Eye'}, 'identificationModule': {'nctId': 'NCT02023268', 'briefTitle': 'Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'LT2762-PIII-08/13'}, 'secondaryIdInfos': [{'id': '2013-A01292-43', 'type': 'REGISTRY', 'domain': 'Agence Nationale de Sécurité du Médicament et des produits de santé'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2762', 'interventionNames': ['Device: T2762']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vismed®', 'interventionNames': ['Device: Vismed®']}], 'interventions': [{'name': 'T2762', 'type': 'DEVICE', 'description': '1 drop in each eye 3 to 6 times daily during 84 days', 'armGroupLabels': ['T2762']}, {'name': 'Vismed®', 'type': 'DEVICE', 'description': '1 drop in each eye 3 to 6 times daily during 84 days', 'armGroupLabels': ['Vismed®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'country': 'France', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}