Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-04-16 @ 7:47 PM
Study NCT ID:
NCT01568593
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe 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': '0473981436', 'title': 'Dr Pascale POULIQUEN', 'organization': 'Laboratoires Thea'}, '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': 'T2750', 'description': 'T2750: 1 drop in each eye 3 to 6 times daily during 84 days', 'otherNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vismed', 'description': 'Vismed: 1 drop in each eye 3 to 6 times daily during 84 days', 'otherNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Ocular Staining (With Oxford Scale - Ranges :0-15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T2750', 'description': 'T2750: 1 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': '-1.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 35 days', 'description': 'Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2750', 'description': 'T2750: 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': '48'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T2750', 'description': 'T2750: 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, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '10', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from the dry eye diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '7.18', 'spread': '6.98', 'groupId': 'BG000'}, {'value': '6.2', 'spread': '5.41', 'groupId': 'BG001'}, {'value': '6.71', 'spread': '6.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-07', 'studyFirstSubmitDate': '2012-03-29', 'resultsFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-24', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Ocular Staining (With Oxford Scale - Ranges :0-15)', 'timeFrame': 'Baseline and 35 days', 'description': 'Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'Comparison of the efficacy and safety of T2750 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\n* Eyelid malposition\n* Known hypersensitivity to one of the components of the study medications or test products.\n* Pregnant or breast-feeding woman.\n* Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).\n* Inability of patient to understand the study procedures and thus inability to give informed consent.\n* Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).\n* Already included once in this study.\n* Patient under guardianship.'}, 'identificationModule': {'nctId': 'NCT01568593', 'briefTitle': 'Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'LT2750-PIII-10/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2750', 'interventionNames': ['Device: T2750']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vismed', 'interventionNames': ['Device: Vismed']}], 'interventions': [{'name': 'T2750', 'type': 'DEVICE', 'description': '1 drop in each eye 3 to 6 times daily during 84 days', 'armGroupLabels': ['T2750']}, {'name': 'Vismed', 'type': 'DEVICE', 'description': '1 drop in each eye 3 to 6 times daily during 84 days', 'armGroupLabels': ['Vismed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}