Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-02-17 @ 3:52 PM
Study NCT ID:
NCT07234318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dryness score assessed by a VAS and Conjunctival hyperemia grading with Photographs (Efron) scale at week 12', 'timeFrame': 'at week 12 versus baseline', 'description': 'Scores will be determined using a 100 mm VAS on which 0 means "no feeling of eye dryness" and 100 means "most imaginable feeling of eye dryness".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease (DED)']}, 'descriptionModule': {'briefSummary': 'The FOCUS study aims to evaluate the clinical efficacy of 0.1% cyclosporine eye drops solution (Vevizye®, Laboratoires THEA) in patients with moderate to severe dry eye disease characterized by ocular surface inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited in University of Vienna', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* No patients with other ophthalmic diseases than DED\n* Chronic dry eye defined as longer than six months since diagnosis\n* OSDI score \\> 22\n* Conjunctival Hyperemia ≥ Grade 3 (Efron Scale)\n* Current use of tear substitutes for at least 3 months not to be considered as sufficient by the investigator/treating physician\n* Need to add cyclosporine eye drops to tear substitutes as judged by the investigator/treating physician\n\nExclusion Criteria:\n\nOphthalmic exclusion criteria\n\n* Far best corrected visual acuity \\< 1/10\n* Severe Dry Eye associated with:\n\n * Eyelid malposition\n * Stevens Johnson Syndrome\n * Corneal dystrophy\n * Ocular neoplasia\n * Filamentous keratitis\n * Corneal neovascularisation\n * Orbital radiotherapy\n * Dry eye related to Graft Versus Host Disease (GVHD)\n* History of any of the following within last 3 months:\n* Systemic treatment of dry eye\n* Systemic treatment of Meibomian Gland Dysfunction (MGD)\n* Isotretinoïde,\n* Cyclosporine,\n* Tacrolimus, Siromilus, Pimecrolimus\n* Punctual plugs\n* History of any of the following within previous six months:\n* ocular trauma\n* ocular infection, Ocular allergy\n* History of any of the following within last 12 months:\n* inflammatory corneal ulcer\n* Herpetic eye infection\n* or uveitis\n* Ocular surgery\n\nSystemic / non ophthalmic exclusion criteria:\n\n•Known hypersensitivity to any of the components of the medical product under investigation or other study medication\n\nSpecific exclusion criteria for women:\n\n* Pregnant or breast-feeding woman.\n* Woman of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception (i.e. hormonal contraceptives, intra-uterine device, contraceptive implant or condoms with spermicide)\n\nExclusion criteria related to general conditions\n\n* Inability of patient to understand the investigation procedures and thus inability to give valid, informed consent.\n* Non-compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)\n* Participation in another clinical study or clinical investigation at the same time as the present investigation\n* Participation to the present clinical investigation during the exclusion period of another clinical study\n* Patient already included once in this clinical investigation\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT07234318', 'briefTitle': 'Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study', 'orgStudyIdInfo': {'id': 'LT10460-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cyclosporin', 'type': 'DRUG', 'description': 'This medicinal product contains cyclosporine 0.1% as an active ingredient and pefluorobutylpentane as vehicle.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Medical Affairs Director', 'role': 'CONTACT', 'email': 'Florence.NOIRT@theapharma.com', 'phone': '+33 4 73 98 14 36'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}