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Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Gel Administered in Patients Affected by Moderate DED

Dry Eye Syndromes Clinical Trial

Official title:
Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study

Clinical Trial Summary

This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

Clinical Trial Description

The purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator.

Patients, after signing the Informed Consent, will enter into a 1-week screening phase during which the baseline tests will be conducted.

Baseline (V0), Day 30 ± 1 week (V1), Day 38 ± 2 days (V2), Day 68 ±1 week (V3) of treatment.

Between V1 and V2 one week of wash out should be performed. Of note, all ophthalmologic evaluations listed in the Flow-Chart will be performed on both eyes of the patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04485533
Study type Interventional
Source VISUfarma SpA
Contact
Status Active, not recruiting
Phase N/A
Start date July 6, 2020
Completion date April 30, 2021
View Details
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