Dry Eye Clinical Trial - to Evaluate the Effectiveness & Safety of

Status Completed

Clinical Trial Summary

A Randomized, Masked (Evaluator), Controlled, Prospective Study Evaluating the Effectiveness and Safety of the Tixel® Medical Device, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Clinical Trial Description

Randomized, open-label study comparing the Tixel device to LipiFlow System. Up to 110 patients (220 eyes) to be randomized in up to 5 clinical sites in the United States. Evaluators will be masked as to the randomization assignments. Both eyes will receive the same randomized assignment and both eyes of each patient will be evaluated at all time points. Data from both eyes will be using in the statistical analysis. The random-effects model adjusts the standard error (SE) and the confidence interval (CI) for within-person correlation between eyes. Protocol Rev. 7.0 update: Addition of protocol extension to the current protocol: stage 1- main protocol for all patients and stage 2- extension protocol to a sub-group of patients only in the Tixel arm for additional follow-up visit 6 months post last treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05162261
Study type	Interventional
Source	Novoxel Ltd.
Contact
Status	Completed
Phase	N/A
Start date	September 19, 2022
Completion date	September 28, 2023

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to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms