NCT05778942

Investigation of Preservative-Free Ophthalmic Solution in Ocular Dryness

Multicentric Clinical Investigation on the Use of Preservative-Free Ophthalmic Solution Based on Sodium Hyaluronate and Xanthan Gum in the Treatment of Eye Discomfort, in Particular in Case of Ocular Dryness

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: SIFI SpA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DEVICE	Eyestil SYNFO	Instillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-11-06
• Completion: 2023-12-19
• First posted: 2023-03-22
• Last updated: 2024-02-06

Locations

4 sites across 1 country: Spain