Clinical trial NCT03953118: Azithromycin for Meibomian Gland Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye
Neuropathic Eye Pain
Ocular Microbiome
Depression, Anxiety
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI) Questionnaire
timeFrame: Baseline to 1 month.
measure: Ocular Surface Disease Index (OSDI) Questionnaire
timeFrame: Baseline to 3 months.
Secondary outcomes:
measure: Ocular surface microbiome testing
timeFrame: Baseline to 1 month.
measure: Ocular surface microbiome testing
timeFrame: Baseline to 3 months.
measure: Dry Eye Questionnaire 5 (DE-5)
timeFrame: Baseline to 1 month.
measure: Dry Eye Questionnaire 5 (DE-5)
timeFrame: Baseline to 3 months.
measure: Neuropathic Pain Inventory for the Eye (NPSI-E)
timeFrame: Baseline to 1 month.
measure: Neuropathic Pain Inventory for the Eye (NPSI-E)
timeFrame: Baseline to 3 months.
measure: Personal Health Questionnaire (PHQ-9)
timeFrame: Baseline to 1 month.
measure: Personal Health Questionnaire (PHQ-9)
timeFrame: Baseline to 3 months.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julie Schallhorn, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Thuy Doan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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