Evaluation of the VisuXL® Performance on Ocular Surface Discomfort, in Professional Water-polo Athletes Exposed to Pool Water for Prolonged Periods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- break-up time (BUT)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 33 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pathologies of the anterior segment
- •Diagnosis of autoimmune diseases (eg SEL, Sjogren)
- •Diagnosis of metabolic diseases (eg diabetes, thyroid malfunction/disorder)
- •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
研究组 & 干预措施
VisuXL® Treatment
干预措施: VisuXL® (Device)
结局指标
主要结局
break-up time (BUT)
时间窗: measured at week 1, 2, 4 and 8 versus baseline
change over time in tear film break-up time (BUT)
次要结局
- Schirmer I test at 5 min (ST) (without anesthesia)(measured at week 1, 2, 4 and 8 versus baseline)
- Tear osmolarity test(measured at week 1, 2, 4 and 8 versus baseline)
- coloration of the ocular surface(measured at week 1, 2, 4 and 8 versus baseline)
- Evaluation of visual acuity(measured at week 1, 2, 4 and 8 versus baseline)
- Subject satisfaction (10 points on the VAS scale)(measured at week 1, 2, 4 and 8)
- Number of beating of eyelashes per minute(measured at week 1, 2, 4 and 8 versus baseline)
- Questionnaire scores (OSDI)(measured at week 1, 2, 4 and 8 versus baseline)