Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT06573606
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2024-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ophthalmic Solution in Diabetic Corneal Alteration
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TBUT', 'timeFrame': '3 months', 'description': 'Tear Breakup Time'}], 'secondaryOutcomes': [{'measure': 'OSDI', 'timeFrame': '3 months', 'description': 'Ocular Surface Disease Index'}, {'measure': 'Corneal Sensitivity', 'timeFrame': '3 months', 'description': 'measured via the "Luneau Cochet-Bonnet Aesthesiometer", results are expressed in cm'}, {'measure': 'Wound Healing', 'timeFrame': '30 hours', 'description': 'Scratch test performed on cell lines using the "Ibidi Culture-Inserts". The test provides hinds on the ability of a cell line to cover a "wound" created in the monolayer. Results are given as % of the area covered'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Eye Disease (DED)']}, 'referencesModule': {'references': [{'pmid': '29747621', 'type': 'BACKGROUND', 'citation': 'Zou X, Lu L, Xu Y, Zhu J, He J, Zhang B, Zou H. Prevalence and clinical characteristics of dry eye disease in community-based type 2 diabetic patients: the Beixinjing eye study. BMC Ophthalmol. 2018 May 10;18(1):117. doi: 10.1186/s12886-018-0781-7.'}, {'pmid': '33362474', 'type': 'BACKGROUND', 'citation': 'Guerrero-Moreno A, Baudouin C, Melik Parsadaniantz S, Reaux-Le Goazigo A. Morphological and Functional Changes of Corneal Nerves and Their Contribution to Peripheral and Central Sensory Abnormalities. Front Cell Neurosci. 2020 Dec 10;14:610342. doi: 10.3389/fncel.2020.610342. eCollection 2020.'}, {'pmid': '31065905', 'type': 'BACKGROUND', 'citation': 'Yoo TK, Oh E. Diabetes mellitus is associated with dry eye syndrome: a meta-analysis. Int Ophthalmol. 2019 Nov;39(11):2611-2620. doi: 10.1007/s10792-019-01110-y. Epub 2019 May 7.'}, {'pmid': '31373862', 'type': 'BACKGROUND', 'citation': 'Posarelli C, Passani A, Del Re M, Fogli S, Toro MD, Ferreras A, Figus M. Cross-Linked Hyaluronic Acid as Tear Film Substitute. J Ocul Pharmacol Ther. 2019 Sep;35(7):381-387. doi: 10.1089/jop.2018.0151. Epub 2019 Aug 2.'}, {'pmid': '16497231', 'type': 'BACKGROUND', 'citation': 'Ledbetter EC, Munger RJ, Ring RD, Scarlett JM. Efficacy of two chondroitin sulfate ophthalmic solutions in the therapy of spontaneous chronic corneal epithelial defects and ulcerative keratitis associated with bullous keratopathy in dogs. Vet Ophthalmol. 2006 Mar-Apr;9(2):77-87. doi: 10.1111/j.1463-5224.2006.00439.x.'}, {'pmid': '28777385', 'type': 'BACKGROUND', 'citation': 'Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018 Jan;28(1):25-31. doi: 10.5301/ejo.5001011. Epub 2018 Feb 19.'}, {'pmid': '29394128', 'type': 'BACKGROUND', 'citation': 'Carlson E, Kao WWY, Ogundele A. Impact of Hyaluronic Acid-Containing Artificial Tear Products on Reepithelialization in an In Vivo Corneal Wound Model. J Ocul Pharmacol Ther. 2018 May;34(4):360-364. doi: 10.1089/jop.2017.0080. Epub 2018 Feb 2.'}, {'pmid': '39797325', 'type': 'DERIVED', 'citation': 'Scarinci F, De Simone G, Ciancimino C, Caggiano C, Pocobelli G, Di Masi A. Enhancing Corneal Sensitivity in Diabetic Patients Through an Innovative Ophthalmic Solution: In Vivo and Vitro Results. J Clin Med. 2025 Jan 3;14(1):245. doi: 10.3390/jcm14010245.'}]}, 'descriptionModule': {'briefSummary': 'Data analyses and revision of the DED symptoms in diabetic subjects. A novel ophthalmic solution containing cross-linked ha (CX-HA) and Chondroitin sulphate (CS) has been made available on the market.\n\nBoth molecules have been widely studied for their viscoelastic and hydrating properties.\n\nNevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.\n\nThis new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data derived from diabetic subject affected by dry eye disease and treated with the ophthalmic solution containing CX-HA and CS will be collected and analysed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic Subjects affected by dry eye disease\n\nExclusion Criteria:\n\n* know allergies to CX-HA\n* know allergies to CS'}, 'identificationModule': {'nctId': 'NCT06573606', 'briefTitle': 'Ophthalmic Solution in Diabetic Corneal Alteration', 'organization': {'class': 'INDUSTRY', 'fullName': 'D&V FARMA srl'}, 'officialTitle': 'Ophthalmic Solution in Diabetic Corneal Alteration', 'orgStudyIdInfo': {'id': 'DIDI01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HA-CS', 'description': 'Diabetic subjects affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked hyaluronic acid (CX-HA) and Chondroitin sulphate (CS).', 'interventionNames': ['Device: CX-HA and CS']}], 'interventions': [{'name': 'CX-HA and CS', 'type': 'DEVICE', 'description': 'Sterile Isotonic ophthalmic solution', 'armGroupLabels': ['HA-CS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00184', 'city': 'Rome', 'country': 'Italy', 'facility': 'San Giovanni-Addolorata Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'D&V FARMA srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'San Giovanni Addolorata Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}