Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
Randomized Self-Controlled Treatment With an Intracanalicular Dexamethasone Insert Compared to Topical Over the Counter Lubrication Therapy in Patients With Bilateral Ocular Surface Disease
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
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.
Inclusion Criteria:A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study: