Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

Ocular Discomfort Clinical Trial

Official title: Evaluation of the VisuXL® Performance on Ocular Surface Discomfort, in Professional Water-polo Athletes Exposed to Pool Water for Prolonged Periods

Status Completed

Clinical Trial Summary

VisuXL® is a medical device that is effective in various ocular surface disorders (ocular dryness, changes in the continuity of the corneal and conjunctival surface, environmental stress, exposure to UV and ionizing radiation, prolonged use of videoterminals, etc.). Therefore, the aim of this study is to demonstrate that the clinical benefits and quality of life of the swimmers, exposed for a long time to water added with chlorine, are strongly linked to the unique composition of the long-term VisuXL® medical device.

Clinical Trial Description

This is a post-market, monocentric, open-label, randomized study of superiority, with the untreated eye considered as a comparator for the eye treated with VisuXL®, to demonstrate the effectiveness of VisuXL® in professional water-polo athletes exposed to pool water after VisuXL® ocular instillations for 2 months. Considered the category of subjects to study, the study is to be considered a fact-finding pilot study in a particular category of subjects.

The study population will be enrolled only after having signed the informed consent; in each enrolled subject, only one eye will be treated with VisuXL®, while the other no, as will be considered the comparator, so the two randomized groups will be divided by treated eyes:

• Untreated control eye

• Eye treated with VisuXL®

Each enrolled subject will be instructed to instill, TID, 1-2 drops of VisuXL® always in the same eye during the entire study, according to the present modality:

• Morning

• Before training (at least one hour before entering the pool)

• After training (maximum one hour after the end of the activity) Subjects will continue to instil 1-2 drops of VisuXL®, TID, always in the same eye, even in days without training (including weekends). ;

Related Conditions & MeSH terms

• Ocular Discomfort

• NCT number: NCT03844737
• Study type: Interventional
• Source: VISUfarma SpA
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Completion date: December 6, 2018