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Completed

NCT Number: NCT03844737

Evaluation of the VisuXL® Performance on Ocular Surface Discomfort

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.

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Key information

Conditions

Ocular Discomfort

Age range

14 year–33 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UO Oculistica, Fondazione Policlinico Universitario A. Gemelli

Roma, 00168, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

VisuXL®

Device

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

Primary outcomes

  1. break-up time (BUT)

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    change over time in tear film break-up time (BUT)

Secondary outcomes

  1. coloration of the ocular surface

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    Analysis to evaluate the differences over time between the two groups on coloration of the ocular surface (corneal and conjunctival) with fluorescein

  2. Schirmer I test at 5 min (ST) (without anesthesia)

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    Analysis to evaluate the differences over time between the two groups on Schirmer I test at 5 min (ST) (without anesthesia)

  3. Number of beating of eyelashes per minute

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    Analysis to evaluate the differences over time between the two groups on number of beating of eyelashes per minute

  4. Tear osmolarity test

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    Analysis to evaluate the differences over time between the two groups on tear osmolarity test

  5. Evaluation of visual acuity

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    Analysis to evaluate the differences over time between the two groups on evaluation of visual acuity

  6. Questionnaire scores (OSDI)

    Time frame: measured at week 1, 2, 4 and 8 versus baseline

    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.

  7. Subject satisfaction (10 points on the VAS scale)

    Time frame: measured at week 1, 2, 4 and 8

    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).

Sponsors and collaborators

Lead sponsor

VISUfarma SpA

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2019
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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