Ophthalmic Solution in Diabetic Corneal Alteration

D&V FARMA srl20 enrolled

Overview

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.

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: * Diabetic Subjects affected by dry eye disease Exclusion Criteria: * know allergies to CX-HA * know allergies to CS

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

Corneal Sensitivity

measured via the "Luneau Cochet-Bonnet Aesthesiometer", results are expressed in cm

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

Data from ClinicalTrials.gov

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