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
Verified date | February 2019 |
Source | VISUfarma SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | UO Oculistica, Fondazione Policlinico Universitario A. Gemelli | Roma |
Lead Sponsor | Collaborator |
---|---|
VISUfarma SpA |
Italy,
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 |
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