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.