Ophthalmic Solution in Diabetic Corneal Alteration
- Conditions
- Dry Eye Disease (DED)
- Interventions
- Device: CX-HA and CS
- Registration Number
- NCT06573606
- Lead Sponsor
- D&V FARMA srl
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Diabetic Subjects affected by dry eye disease
- know allergies to CX-HA
- know allergies to CS
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HA-CS CX-HA and 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).
- Primary Outcome Measures
Name Time Method TBUT 3 months Tear Breakup Time
- Secondary Outcome Measures
Name Time Method OSDI 3 months Ocular Surface Disease Index
Corneal Sensitivity 3 months measured via the "Luneau Cochet-Bonnet Aesthesiometer", results are expressed in cm
Wound Healing 30 hours 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
Trial Locations
- Locations (1)
San Giovanni-Addolorata Hospital
🇮🇹Rome, Italy