Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Discomfort
• Intervention / Treatment: Device: VisuXL®

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • UO Oculistica, Fondazione Policlinico Universitario A. Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 31 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VisuXL® Treatment	Device: VisuXL®; Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
break-up time (BUT)	change over time in tear film break-up time (BUT)	measured at week 1, 2, 4 and 8 versus baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coloration of the ocular surface	Analysis to evaluate the differences over time between the two groups on coloration of the ocular surface (corneal and conjunctival) with fluorescein	measured at week 1, 2, 4 and 8 versus baseline
Schirmer I test at 5 min (ST) (without anesthesia)	Analysis to evaluate the differences over time between the two groups on Schirmer I test at 5 min (ST) (without anesthesia)	measured at week 1, 2, 4 and 8 versus baseline
Number of beating of eyelashes per minute	Analysis to evaluate the differences over time between the two groups on number of beating of eyelashes per minute	measured at week 1, 2, 4 and 8 versus baseline
Tear osmolarity test	Analysis to evaluate the differences over time between the two groups on tear osmolarity test	measured at week 1, 2, 4 and 8 versus baseline
Evaluation of visual acuity	Analysis to evaluate the differences over time between the two groups on evaluation of visual acuity	measured at week 1, 2, 4 and 8 versus baseline
Questionnaire scores (OSDI)	Analysis to evaluate the differences over time between the two groups on questionnaire scores (OSDI). The overall Ocular Surface Disease score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease.	measured at week 1, 2, 4 and 8 versus baseline
Subject satisfaction (10 points on the VAS scale)	Analysis to evaluate the differences over time between the two groups on subject satisfaction. (VAS: scale where patient has to specify level of satisfaction by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no satisfaction while 10 represents the highest level).	measured at week 1, 2, 4 and 8

Collaborators and Investigators

• Sponsor: VISUfarma SpA

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): December 6, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: VF-OS-003/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No