Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Status Terminated

Clinical Trial Summary

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

Clinical Trial Description

This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04413253
Study type	Interventional
Source	Eye Surgeons of Indiana
Contact
Status	Terminated
Phase	Phase 4
Start date	August 1, 2020
Completion date	April 11, 2022

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