Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-25 @ 12:26 PM
Study NCT ID:
NCT07169695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003233', 'term': 'Conjunctivitis, Allergic'}], 'ancestors': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072776', 'term': 'Slit Lamp Microscopy'}, {'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (Day 1) at Day 29 (Week 4) in Corneal Fluorescein Staining (CFS) grade assessed by the (0-5) modified Oxford scale in the study eye.', 'timeFrame': 'From Day 1 to Day 29'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vernal Keratoconjunctivitis'], 'conditions': ['Moderate to Severe Vernal Keratoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants with Moderate to Severe Vernal Keratoconjunctivitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Informed consent signed and dated\n* Male or female participant from 4 years to less than 18 years old.\n* Participant with grading score of 3 or 4 on the Bonini scale for clinical grading of VKC in each eye.\n\nMain Exclusion Criteria:\n\nParticipants must not have any conditions which might exclude them from participating, could interfere with the study, or pose an unacceptable risk to their health.'}, 'identificationModule': {'nctId': 'NCT07169695', 'briefTitle': 'A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Efficacy and Safety Assessment of T1695 Ophthalmic Suspension, Versus Ciclosporin Ophthalmic Emulsion, in Participants With Moderate to Severe Vernal Keratoconjunctivitis (VKC).', 'orgStudyIdInfo': {'id': 'LT1695-201'}, 'secondaryIdInfos': [{'id': '2025-521567-12-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T1695', 'description': 'The participant should instill T1695.', 'interventionNames': ['Diagnostic Test: Slit Lamp Examination', 'Diagnostic Test: Far Best Corrected Visual Acuity (BCVA)', 'Drug: T1695', 'Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ciclosporin', 'description': 'The participant should instill Ciclosporin.', 'interventionNames': ['Diagnostic Test: Slit Lamp Examination', 'Diagnostic Test: Far Best Corrected Visual Acuity (BCVA)', 'Drug: Ciclosporin', 'Diagnostic Test: Corneal fluorescein staining score on modified Oxford scale']}], 'interventions': [{'name': 'Slit Lamp Examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'The participant will have a slit lamp examination', 'armGroupLabels': ['Ciclosporin', 'T1695']}, {'name': 'Far Best Corrected Visual Acuity (BCVA)', 'type': 'DIAGNOSTIC_TEST', 'description': "The participant 's BCVA will be evaluated.", 'armGroupLabels': ['Ciclosporin', 'T1695']}, {'name': 'T1695', 'type': 'DRUG', 'description': 'The participant should instill T1695.', 'armGroupLabels': ['T1695']}, {'name': 'Ciclosporin', 'type': 'DRUG', 'description': 'The participant should instill Ciclosporin.', 'armGroupLabels': ['Ciclosporin']}, {'name': 'Corneal fluorescein staining score on modified Oxford scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'One drop of fluorescein will be instilled to assess the fluorescein staining score on the modified Oxford scale.', 'armGroupLabels': ['Ciclosporin', 'T1695']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Corentin LE CAMUS', 'role': 'CONTACT', 'email': 'Corentin.LECAMUS@theapharma.com', 'phone': '+33473981436'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}