Cross-linked CMC and Silk Proteins in Eye Disease
- Conditions
- Dry Eye Disease (DED)
- Interventions
- Device: CX-HA and CS
- Registration Number
- NCT06605365
- Lead Sponsor
- D&V FARMA srl
- Brief Summary
Data analyses and revision of the DED symptoms. A novel ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP) has been made available on the market.
Both molecules have been widely studied for their viscoelastic and hydrating, and wound healing properties.
This new ophthalmic solution is the first on the market formulated with a CX-CMC and SP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Subjects affected by dry eye disease
- know allergies to CX-CMC
- know allergies to SP
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CXC-SP CX-HA and CS Subjects affected by dry eye disease are treated with the new ophthalmic solution containing cross-linked CMC (CX-CMC) and Silk Proteins (SP).
- 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
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
UV and Blue light absorption 0 hours The ability of the solution to absorb UV and blue light will be evaluated via a spectrophotometer. The outcome will be measured in arbitrary units.
Trial Locations
- Locations (1)
San Giovanni-Addolorata Hospital
🇮🇹Rome, Italy