Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT05931861
Status:
COMPLETED
Last Update Posted:
2025-01-31
First Post:
2023-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
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': 'Corentin.LECAMUS@theapharma.com', 'phone': '0473981436', 'title': 'Clinical Affairs Director', 'organization': 'Laboratoires Théa'}, 'certainAgreement': {'otherDetails': 'The data resulting from this clinical investigation will be the proprietary information of Sponsor. An investigator shall not publish any data (poster, abstract, paper, etc.) without having consulted with Laboratoires THÉA in advance.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from informed consent signature (Day 1) to Final visit (Day 36).', 'eventGroups': [{'id': 'EG000', 'title': 'T2769', 'description': 'One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.\n\nT2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'T2769', 'description': 'One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.\n\nT2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'CLDEQ- score is assessed at Day 1 and Day 36', 'description': 'The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.\n\nCLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37.\n\n37 is the worst score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T2769', 'description': 'One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.\n\nT2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'T2769', 'description': 'One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.\n\nT2769: T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.7', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-04', 'size': 1241353, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-08T04:44', 'hasProtocol': True}, {'date': '2023-10-26', 'size': 584590, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-08T04:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2023-06-23', 'resultsFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-08', 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Total Score.', 'timeFrame': 'CLDEQ- score is assessed at Day 1 and Day 36', 'description': 'The primary endpoint is the change from baseline (Day 1) to Day 36 in the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.\n\nCLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37.\n\n37 is the worst score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline.\n\nThe primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Informed consent signed and dated\n* Patient aged ≥ 18 years old\n* Well fitted contact lenses (CL) according to the investigator judgement\n* Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study\n* Patient with an Ocular Surface Disease Index (OSDI) score ≥ 18\n* CLDEQ-8 score ≥ 12\n\nMain Exclusion Criteria:\n\n* Far Best-Corrected Visual Acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 ETDRS letters).\n* Severe blepharitis\n* Severe Meibomian gland dysfunction\n* Palpebral or nasolacrimal disorders\n* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.'}, 'identificationModule': {'nctId': 'NCT05931861', 'briefTitle': 'Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.', 'orgStudyIdInfo': {'id': 'LT2769-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2769', 'description': 'One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.', 'interventionNames': ['Device: T2769']}], 'interventions': [{'name': 'T2769', 'type': 'DEVICE', 'description': 'T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.', 'armGroupLabels': ['T2769']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Medical Center "Oxycom"', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'city': 'Smolyan', 'country': 'Bulgaria', 'facility': '"Asmp Ob - Ip Glm" Eood', 'geoPoint': {'lat': 41.57439, 'lon': 24.71204}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center For Eye Health "Focus"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Specialized Ophthalmological Hospital For Active Treatment "Pentagram"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'Medical Center "Vereya"', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}], 'overallOfficials': [{'name': 'Christina Grupcheva, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Individual Practice for Specialized Ophthalmology Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}