NCT06573606|Completed
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Sponsor study identifier
observational
20
1 country
1
Study Start
September 1, 2021
Actual (reported)Primary Completion
September 1, 2022
Actual (reported)Study Completion
September 1, 2022
Actual (reported)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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2021
Actual (reported)September 1, 2022
Actual (reported)September 1, 2022
Actual (reported)August 21, 2024
Actual (reported)August 27, 2024
Actual (reported)TBUT
Tear Breakup Time
3 months
OSDI
3 months
Corneal Sensitivity
3 months
Wound Healing
30 hours
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).
Sterile Isotonic ophthalmic solution
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
San Giovanni-Addolorata Hospital
Rome, 00184, Italy
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.
20 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2024
First Posted
August 27, 2024
Study Start
September 1, 2021
Actual (reported)Study on Safety and Performance of an Artificial Tear in Dry Eye Treatment in Subjects With Ocular Surface Inflammation
Contact the study team to confirm eligibility.
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.
Primary Completion
September 1, 2022
Actual (reported)Study Completion
September 1, 2022
Actual (reported)Last Updated
August 29, 2024
Record last verified: 2024-08
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