Ophthalmic Solution in Diabetic Corneal Alteration

Completed

• Conditions: Dry Eye Disease (DED)

• 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

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diabetic Subjects affected by dry eye disease

Exclusion Criteria

• know allergies to CX-HA
• know allergies to CS

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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