Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT03830359
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2019-01-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety of T2769 in Dry Eye Disease
Sponsor:
Organization:
Raw JSON
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'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'T2769', 'description': 'T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily of T2769 for 42 days', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Symptomatology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T2769', 'description': 'T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily\n\nT2769: 62 patients treated by T2769 for 42 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.9', 'spread': '23.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 42', 'description': 'Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'm-ITT population : all enrolled patients having received at least one dose of the IP and with at least one baseline and post-baseline efficacy assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2769', 'description': 'T2769 : 1 drop in each eye 3 to 6 times daily during 42 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'T2769', 'description': 'T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily\n\nT2769: 62 patients treated by T2769 for 42 days'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Tunisia', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-13', 'size': 3620739, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-15T11:35', 'hasProtocol': True}, {'date': '2019-07-04', 'size': 805225, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-15T11:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2019-01-07', 'resultsFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-15', 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Symptomatology', 'timeFrame': 'Baseline and Day 42', 'description': 'Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'Efficacy of T2769 in Dry Eye Desease', 'detailedDescription': 'Multicenter and open study'}, '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 screening\n\nExclusion Criteria:\n\n* Best far corrected visual acuity ≤ 2/10\n* Severe blepharitis Severe dry eye'}, 'identificationModule': {'nctId': 'NCT03830359', 'briefTitle': 'Efficacy, Safety of T2769 in Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome', 'orgStudyIdInfo': {'id': 'LT2769-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2769', 'description': 'T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily', 'interventionNames': ['Other: T2769']}], 'interventions': [{'name': 'T2769', 'type': 'OTHER', 'otherNames': ['Ophthalmic solution'], 'description': 'At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days', 'armGroupLabels': ['T2769']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5100', 'city': 'Mahdia', 'country': 'Tunisia', 'facility': 'Hôpital Universitaire Tahar Sfar', 'geoPoint': {'lat': 35.50472, 'lon': 11.06222}}, {'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': '"Hôpital Universitaire Fattouma Bourguiba', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'city': 'Tunis', 'country': 'Tunisia', 'facility': '"Hôpital de Forces de Sécurité Intérieure La Marsa', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Lamia El Fekih, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'fekihlamia63@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}