Dry Eye Disease (DED)
Conditions
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.
Interventions
DEVICECX-HA and CS
Sterile Isotonic ophthalmic solution
Sponsors
San Giovanni Addolorata Hospital
D&V FARMA srl
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetic Subjects affected by dry eye disease
Exclusion criteria
* know allergies to CX-HA * know allergies to CS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TBUT | 3 months | Tear Breakup Time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed