NCT03953118

Azithromycin for Meibomian Gland Disease

A Randomized, Controlled Trial to Evaluate the Role of Oral Azithromycin in the Treatment of Symptomatic Meibomian Gland Disease and Its Effect on the Ocular Surface Microbiome

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye
• Neuropathic Eye Pain
• Ocular Microbiome
• Depression, Anxiety

Interventions

Type	Name	Description
DRUG	Azithromycin Oral Product	Oral azithromycin dosed at 1 gram per week for 3 weeks
DRUG	Placebo Oral	Oral placebo tablet

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-05-16
• Last updated: 2025-08-06
• Results posted: 2025-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study