Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

NCT ID: NCT03844737

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2018-12-06

Brief 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.

Detailed 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).

Conditions

Ocular Discomfort

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VisuXL® Treatment

Group Type: EXPERIMENTAL

VisuXL®

Intervention Type: DEVICE

Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods.

Interventions

VisuXL®

Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male subjects aged 14 to 33 years

2. Schirmer test I> 10 mm at 5 '

3. Willingness to participate in the study and possibility to sign the ICF; for athletes aged <18 years: parents' agreement for the participation of the child in the study

4. Discomfort of the ocular surface

Exclusion Criteria

1. Pathologies of the anterior segment

2. Diagnosis of autoimmune diseases (eg SEL, Sjogren)

3. Diagnosis of metabolic diseases (eg diabetes, thyroid malfunction/disorder)

4. Entropion

5. Trichiasis

6. Deficiency of androgens sex hormones

7. Taking medications that can interfere with the secretion of the lacrimal gland

8. Connective tissue disease

9. Prior eye surgery

10. Hypersensitivity to the active ingredients contained in VisuXL®

11. Use of artificial tears in the 15 days before the start of the study

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 33 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VISUfarma SpA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UO Oculistica, Fondazione Policlinico Universitario A. Gemelli

Roma, , Italy

Countries

Italy

Other Identifiers

VF-OS-003/2018

Identifier Type: -

Identifier Source: org_study_id