Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2021-09-01
2022-09-01
Brief Summary
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Both molecules have been widely studied for their viscoelastic and hydrating properties.
Nevertheless, the use of CS in ophthalmology has been limited since, routinely, the molecule is of animal origins.
This new ophthalmic solution is the first on the market formulated with a CS of non-animal origin.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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HA-CS
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).
CX-HA and CS
Sterile Isotonic ophthalmic solution
Interventions
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CX-HA and CS
Sterile Isotonic ophthalmic solution
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* know allergies to CS
18 Years
ALL
No
Sponsors
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San Giovanni Addolorata Hospital
OTHER
D&V FARMA srl
INDUSTRY
Responsible Party
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Locations
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San Giovanni-Addolorata Hospital
Rome, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DIDI01
Identifier Type: -
Identifier Source: org_study_id
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