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Clinical Trial Summary

To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management


Clinical Trial Description

This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04237012
Study type Interventional
Source The Eye Centers of Racine and Kenosha
Contact
Status Completed
Phase Phase 4
Start date December 16, 2019
Completion date December 30, 2021

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