Status:
COMPLETED
Evaluation of the VisuXL® Performance on Ocular Surface Discomfort
Lead Sponsor:
VISUfarma SpA
Conditions:
Ocular Discomfort
Eligibility:
MALE
14-33 years
Phase:
NA
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03844737
Start Date
October 8 2018
End Date
December 6 2018
Last Update
February 18 2019
Active Locations (1)
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1
UO Oculistica, Fondazione Policlinico Universitario A. Gemelli
Roma, Italy, 00168