Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-04 @ 8:45 PM
Study NCT ID:
NCT07007702
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Schirmer test strips stored for proteomics and lipidomics analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction with Visual Analog Scale (0-10) at week 12 - Descriptive analysis', 'timeFrame': 'at week 12', 'description': 'Scores will be determined using a 100 mm VAS on which 0 means "I do not agree" and 100 means "I totally agree". The following questions will be assessed using VAS:\n\n"I feel satisfied using this treatment" "With these eye drops, I have a feeling of freshness" "With these eye drops, I have a feeling of relief" "This product contributed to reduce my pain due to eye dryness" "This product is comfortable"'}, {'measure': 'Conjunctival hyperaemia assesment with Efron scale at week 12', 'timeFrame': 'week 12', 'description': 'Conjunctival hyperemia grading with Photographs (Efron) scale at week 12\n\n* Descriptive analysis\n* Cross table baseline vs week 12; McNemar Bowker (0) = None\n\n 1. = Trace\n 2. = Mild\n 3. = Moderate\n 4. = Severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease (DED)']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, open, monocentric study is to evaluate the clinical efficacy of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA in 30 patients with chronic dry eye disease and associated ocular surface inflammation.\n\nThe main question it aims to answer is:\n\n\\- To assess the improvement of conjunctival hyperemia as well as subjective symptoms in patients with moderate to severe dry eye.\n\nParticipants will be asked to use T2769 on a daily basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 30 patients with moderate to severe dry eye disease and associated inflammation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Normal ophthalmic findings except dry eye disease\n* Chronic dry eye defined as longer than six months since diagnosis\n* OSDI ≥ 22\n* Conjunctival Hyperemia≥ Grade 3 (Efron Scale)\n* Current use of topical lubricants since at least 3 months\n\nExclusion Criteria:\n\nOphthalmic exclusion criteria\n\n* Best far corrected visual acuity \\< 1/10\n* Severe Dry Eye associated with:\n\n * Eyelid malposition\n * Sjogren Syndrome\n * Stevens Johnson Syndrome\n * Corneal dystrophy\n * Ocular neoplasia\n * Filamentous keratitis\n * Corneal neovascularisation\n * Orbital radiotherapy\n * Dry eye related to GVHD\n* History of any of the following within last 3 months:\n* Systemic treatment of dry eye\n* Systemic treatment of 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 device 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)\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': 'NCT07007702', 'briefTitle': 'Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Anti-inflammatory Effects and Clinical Efficacy of Topical Thealoz Total Eye Drops in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation', 'orgStudyIdInfo': {'id': 'LT2769-005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group receiving T2769', 'interventionNames': ['Device: T2769']}], 'interventions': [{'name': 'T2769', 'type': 'DEVICE', 'description': 'Preservative-free combination of trehalose, sodium hyaluronate and N-Acetyl Aspartyl Glutamic Acid', 'armGroupLabels': ['Group receiving T2769']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitätsklinik für Klinische Pharmakologie, Allgemeines Krankenhaus Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}