Cross-linked CMC and Silk Proteins in Eye Disease

D&V FARMA srl20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dry Eye Disease (DED)

Interventions

CX-HA and CSDEVICE

Sterile Isotonic ophthalmic solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects affected by dry eye disease Exclusion Criteria: * know allergies to CX-CMC * know allergies to SP

Locations (1)

San Giovanni-Addolorata Hospital

Rome, Italy

Outcomes

Primary Outcomes

TBUT

Tear Breakup Time

Time frame: 3 months

Secondary Outcomes

OSDI

Ocular Surface Disease Index

Time frame: 3 months

Wound Healing

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

Time frame: 30 hours

UV and Blue light absorption

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.

Time frame: 0 hours

Data from ClinicalTrials.gov

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