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

Eye Surgeons of Indiana

Status and phase

Completed

Phase 4

Conditions

Dry Eye Syndromes

Treatments

Procedure: LipiFlow Thermal Pulsation

Drug: Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT04413279

The DIERKER Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

18 years of age or older
Evaporative DED with MGD and clinically significant inflammation
Willing and able to comply with clinic visits and study related procedures
Willing and able to sign the informed consent form

Exclusion criteria

A patient who meets any of the following criteria will be excluded from the study:

Patients under the age of 18.
Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
Active infectious systemic disease
Active infectious ocular or extraocular disease
Altered nasolacrimal flow of either acquired, induced, or congenital origin
Hypersensitivity to dexamethasone
Patient being treated with either topical, oral, or intravenous steroids
Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator