NCT04413279

Lipiflow Treatment Alone vs. Lipiflow + Dextenza Treatment for Dry Eye Disease

Intracanalicular Dexamethasone Used in Conjunction With LipiFlow for the Treatment of Meibomian Gland Dysfunction in Patients With Evaporative Dry Eye Disease and Evidence of Clinically Significant Inflammation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (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 evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing LipiFlow Thermal Pulsation.

Detailed description

This prospective, open-label, single-center, non-randomized, investigator-sponsored clinical study seeks to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation compared to LipiFlow Thermal Pulsation alone. In addition, this study will evaluate the ease of Dextenza insertion and the patient preference for therapy. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo LipiFlow Thermal Pulsation on the same day. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye), while the other eye will be assigned to a receive a sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. Per patient, the study period will last for approximately 12 weeks after the LipiFlow procedure, consisting of one screening visit, one treatment v4isit and 3 post-procedure follow-up visits (week 1, week 4 and week 12). At week 1, week 4 and week 12, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 4 months.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
PROCEDURE	LipiFlow Thermal Pulsation	To manage patients with dry eye disease secondary to MGD
DRUG	Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation	to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-06-02
• Last updated: 2022-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study