Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness

Status Completed

Clinical Trial Summary

This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness

Clinical Trial Description

Primary objective ▪ To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline. Secondary objectives - To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the NEI scale after 14 days of treatment and after 3 months of treatment compared to baseline. - To evaluate conjunctival hyperemia index assessed by OCULUS Keratograph after 14 days, 1 month and 3 months of treatment compared to baseline. - To evaluate the tear film stability as objectified by the tear film break-up time (TFBUT) test after 14 days, 1 month and 3 months of study treatment initiation compared to baseline. - To evaluate the changes on the Best Corrected Visual Acuity (BCVA) measured by the "Early Treatment Diabetic Retinopathy Study" (ETDRS) after 14 days, 1 month and 3 months of study treatment initiation compared to baseline. - To compare patients reported outcomes with baseline, using specifically: - the patient's reported Symptom Assessment questionnaire iN Dry Eye (SANDE) after 1 and 3 months of treatment; - the patient's Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire after 1 and 3 months of treatment. - To evaluate the safety and compliance of the medical device throughout the entire study period. ;

Study Design

Related Conditions & MeSH terms

Dry Eye Syndromes

Clinical Trial Details

NCT number	NCT05778942
Study type	Observational
Source	SIFI SpA
Contact
Status	Completed
Phase
Start date	February 23, 2023
Completion date	December 19, 2023

View Details

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