Overview

Dextenza With ILUX for Treatment of MGD

Status:
Enrolling by invitation
Trial end date:
2021-05-30
Target enrollment:
0
Participant gender:
All
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 iLUX MGD Treatment System.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Warrenville Eyecare
Treatments:
Dexamethasone
Prednisone
Criteria
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