Azithromycin for Meibomian Gland Disease

University of California San Francisco (UCSF)

Status and phase

Terminated

Phase 4

Conditions

Dry Eye

Depression, Anxiety

Neuropathic Eye Pain

Ocular Microbiome

Treatments

Drug: Azithromycin Oral Product

Drug: Placebo Oral

Study type

Interventional

Funder types

Other

Identifiers

NCT03953118

17-23877

Details and patient eligibility

About

This study aims to elucidate the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction.

Full description

This is a randomized, placebo-controlled, double masked trial of the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction. Dry eye syndrome (DES) is a persistent feeling of ocular discomfort that encompasses dryness, irritation, foreign body sensation and burning. In the United States, it is the most common non-refractive cause of visits to eye care providers, and has been shown to have a significant impact on quality of life of patients who suffer from this condition. most common cause of DES is Meibomian gland disease (MGD). In the vast majority of cases, MGD is not binding, but rather causes persistant ocular discomfort.

Oral antibiotics, particularly the tetracyclines and macrolides, are frequently prescribed for the treatment of MGD. There is little good-quality evidence to support this practice. This study is designed to evaluate the effectiveness of oral azithromycin on patient-reported dry eye symptoms. Concomitantly, we will also study the composition of the ocular surface microbiome in MGD, and its response for oral antibiotics.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.