Clinical trial NCT06573606: Ophthalmic Solution in Diabetic Corneal Alteration
Official title: Ophthalmic Solution in Diabetic Corneal Alteration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Disease (DED)
Lead sponsor: D&V FARMA srl
Sponsor class: INDUSTRY
Collaborators: name: San Giovanni Addolorata Hospital
First posted: 2024-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diabetic Subjects affected by dry eye disease

Exclusion Criteria:

* know allergies to CX-HA
* know allergies to CS

Primary outcomes:
measure: TBUT
timeFrame: 3 months
Secondary outcomes:
measure: OSDI
timeFrame: 3 months
measure: Corneal Sensitivity
timeFrame: 3 months
measure: Wound Healing
timeFrame: 30 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Giovanni-Addolorata Hospital
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.