Azithromycin for Meibomian Gland Disease

Phase 4TerminatedNCT03953118

University of California, San Francisco2 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Neuropathic Eye Pain Ocular Microbiome Depression, Anxiety

Interventions

Azithromycin Oral ProductDRUG

Oral azithromycin dosed at 1 gram per week for 3 weeks

Placebo OralDRUG

Oral placebo tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of California San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Ocular Surface Disease Index (OSDI) Questionnaire

Ocular surface disease index - used to evaluate the degree of dry eye symptoms. Scores will range from 0 to 48, where 48 indicates severe dry eye.

Time frame: Baseline to 1 month

Ocular Surface Disease Index (OSDI) Questionnaire

Ocular surface disease index - used to evaluate the degree of dry eye symptoms. Scores will range from 0 to 48, where 48 indicates severe dry eye.

Time frame: Baseline to 3 months

Secondary Outcomes

Ocular Surface Microbiome Testing

To evaluate the composition of the ocular surface microbiome using Shannon's diversity index. The alpha diversity (local species pool) of the population will be analyzed and compared pre-and post-treatment within and between the azithromycin and control groups. The difference between the bacterial microbiome in the azithromycin and placebo arm will be assessed using a PERMANOVA with an L2 norm distance measure. Secondary analyses will include L1 and L0 norms, as well as a phylogenetic distance. In addition, we will assess whether bacterial alpha diversity is decreased in the antibiotic treated arm with the primary outcome being the Simpson's index (L2), with secondary analyses assessing Shannon's (L1) and Richness (L0).

Time frame: Baseline to 1 month

Ocular Surface Microbiome Testing

Data from ClinicalTrials.gov

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