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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VisuXL® Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisuXL® | Device | Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UO Oculistica, Fondazione Policlinico Universitario A. Gemelli | Roma | 00168 | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2019 | |
| Reset | Aug 22, 2019 | |
| Release | Aug 29, 2019 | |
| Reset | Sep 26, 2019 | |
| Release | Sep 27, 2019 | |
| Reset | Oct 18, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2019 | Aug 22, 2019 | |||
| Aug 29, 2019 |
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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 |
| Sep 26, 2019 |
| Sep 27, 2019 | Oct 18, 2019 |