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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844737
• Other study ID #: VF-OS-003/2018
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: December 6, 2018

Study information

• Verified date: February 2019
• Source: VISUfarma SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 6, 2018
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 33 Years

Eligibility

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

Related Conditions & MeSH terms

• Ocular Discomfort

Intervention

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

Locations

Country	Name	City	State
Italy	UO Oculistica, Fondazione Policlinico Universitario A. Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
VISUfarma SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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