Azithromycin for Meibomian Gland Disease

Phase 4

Conditions: Dry Eye
Depression, Anxiety
Neuropathic Eye Pain
Ocular Microbiome

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

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral	-
Azithromycin	Azithromycin Oral Product	-

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index (OSDI) Questionnaire	Baseline to 3 months.	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.

Secondary Outcome Measures

Name	Time	Method
Neuropathic Pain Inventory for the Eye (NPSI-E)	Baseline to 3 months.	Neuropathic pain inventory for the eye - used to study neuropathic vs stimulatory eye pain.
Ocular surface microbiome testing	Baseline to 3 months.	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).
Dry Eye Questionnaire 5 (DE-5)	Baseline to 3 months.	Dry eye questionnaire 5 - used to evaluate the degree of dry eye symptoms. Scores range from 0-22. A score of 0 represents the minimum dry eye symptoms someone may have and a score of 22 represents the maximum dry eye symptoms someone may have.
Personal Health Questionnaire (PHQ-9)	Baseline to 3 months.	Personal Health Questionnaire - a brief anxiety and depression questionnaire. Will be used in this study to evaluate the interaction between depression/anxiety and response to treatment.

Locations (1): University of California San Francisco
🇺🇸
San Francisco, California, United States