Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion
Julie Schallhorn, MD, MS(ucsf)Thuy Doan, MD, PhD(ucsf)

Description

Summary

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

Official Title

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

Details

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.

Keywords

Dry Eye Neuropathic Eye Pain Ocular Microbiome Depression, Anxiety Eye Pain Azithromycin Oral Product Azithromycin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Location

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States

Lead Scientists

  • Julie Schallhorn, MD, MS (ucsf)
    Julie Schallhorn, MD, MS is Assistant Professor of Ophthalmology at UCSF. Dr. Schallhorn received her undergraduate degree in Chemical Engineering from UCLA, and her Master’s degree in Bioengineering from UCSD. She then completed medical training at the University of Southern California Keck School of Medicine, and her ophthalmology residency at UCSF.
  • Thuy Doan, MD, PhD (ucsf)
    Assistant Professor, Proctor Foundation. Authored (or co-authored) 44 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03953118
Phase
Phase 4
Study Type
Interventional
Last Updated