NCT04413253

Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Eye Surgeons of Indiana · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Lifitegrast 5% Ophthalmic Solution	To reduce signs and symptoms of dry eye disease
DRUG	Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution	To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2020-06-02
• Last updated: 2022-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study