Overview

Azithromycin for Meibomian Gland Disease

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
This study aims to elucidate the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Francisco
Treatments:
Azithromycin
Criteria
Inclusion Criteria:

- Symptomatic Meibomian gland disease, defined as patient-reported ocular surface
symptoms such as dryness, grittiness, foreign body sensation, or eye fatigue in
combination with clinically identifiable Meibomian gland disease with Grade 2 or
greater involvement on the Meibomian Gland Grading Scale (Section XV, item 2).

- OSDI Score greater than or equal to 20

- Ability to give informed consent

Exclusion Criteria:

- Age less than 18 years

- Allergy or intolerance to oral azithromycin or topical dexamethasone

- Allergy or intolerance to the preservatives used in topical ophthalmic 0.1%
dexamethasone: sodium bisulfite, phenylethyl alcohol, benzalkonium chloride

- History of prolonged QT interval, history of torsades des pointes, congenital long QT
syndrome, bradyarrhythmias, heart failure

- Patients currently taking medications that prolong the QT interval (Table 1)

- Aqueous deficiency dry eye defined as Schirmer's strip testing without anesthesia with
£ 5mm of tears on two separate tests.

- Ocular surface inflammatory disease, including cicatrizing conjunctivitis, graft
versus host disease, Stevens Johnson syndrome

- Atopic disease with ocular involvement

- Limbal stem cell deficiency

- Oral or topical ophthalmic antibiotic use within the last 90 days

- Oral prednisone use >5mg per day

- Topical ophthalmic steroid use within the past 30 days

- Topical ophthalmic anti-inflammatory (including non-steroidal anti-inflammatory
medications, lifitegrast, or cyclosporine) use within the past 30 days

- Patients who are currently pregnant, planning on becoming pregnant during the study
period, or currently breastfeeding.