Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

NCT03844737 | Completed

• 1 other identifier: VF-OS-003/2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• coloration of the ocular surface

  measured at week 1, 2, 4 and 8 versus baseline

• 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

  measured at week 1, 2, 4 and 8 versus baseline

• Tear osmolarity test

  measured at week 1, 2, 4 and 8 versus baseline

• Evaluation of visual acuity

  measured at week 1, 2, 4 and 8 versus baseline

Study Arms (1)

VisuXL® Treatment

EXPERIMENTAL

Device: VisuXL®

Interventions

VisuXL® DEVICE

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

VisuXL® Treatment

Eligibility Criteria

• Age: 14 Years - 33 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male subjects aged 14 to 33 years
• Schirmer test I\> 10 mm at 5 '
• 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
• Discomfort of the ocular surface

You may not qualify if:

• Pathologies of the anterior segment
• Diagnosis of autoimmune diseases (eg SEL, Sjogren)
• Diagnosis of metabolic diseases (eg diabetes, thyroid malfunction/disorder)
• Entropion
• Trichiasis
• Deficiency of androgens sex hormones
• Taking medications that can interfere with the secretion of the lacrimal gland
• Connective tissue disease
• Prior eye surgery
• Hypersensitivity to the active ingredients contained in VisuXL®
• Use of artificial tears in the 15 days before the start of the study

Sponsors & Collaborators

• VISUfarma SpA: lead

Study Sites (1)

UO Oculistica, Fondazione Policlinico Universitario A. Gemelli

Roma, 00168, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 18, 2019
• Study Start: October 8, 2018
• Primary Completion: December 6, 2018
• Study Completion: December 6, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Locations

IT (1)