Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

Medical University of Vienna23 enrolled

Overview

Meibomian gland dysfunction (MGD) is among the leading causes for dry eye syndrome (DES), affecting millions of people worldwide. We have shown in a previous study that tear film thickness (TFT) is reduced in patients with DES and that this reduction correlates with tear break up time (BUT) as well as with the severity of subjective symptoms. Even though systemic tetracyclines as well as topical azithromycin can be used for the treatment of MGD, it seems that topical azithromycin is more effective than tetracyclines and also has the advantage of better tolerability. The hypothesis of the present study is that topical treatment with azithromycin leads to a more pronounced increase in TFT compared to oral doxycycline in patients with DES caused by MGD. The objective of this study is to compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with DES caused by MGD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Syndromes Meibomian Gland Dysfunction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women aged over 18 years * Signs of meibomian gland plugging or expressibility of the meibomian glands. * DES most likely caused by MGD, no other cause identifiable which is more likely (e.g. intake of concomitant medication that could induce DES, systemic diseases such as systemic arthritis or diabetes), as judged by the investigator * Signed and dated written informed consent. * History of dry eye syndrome for at least 3 months * Normal ophthalmic findings except dry eye syndrome and MGD, ametropia \< 6 Dpts * BUT ≤ 10 seconds Exclusion Criteria: * Participation in a clinical trial in the 3 weeks before the screening visit * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator * Sjögren's syndrome * Stevens-Johnson syndrome * Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator * Treatment with corticosteroids in the 4 weeks preceding the study * Wearing of contact lenses * Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants Ocular infection * Ocular surgery in the 6 months preceding the study * Pregnancy, planned pregnancy or lactating * Contraindication against the use of topical azithromycin or oral doxycycline

Outcomes

Primary Outcomes

Change in tear film thickness

Change in tear film thickness measured with high resolution OCT before, during and after treatment period.

Time frame: 8 weeks

Secondary Outcomes

Change in lipid layer thickness

Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.

Time frame: 8 weeks

Change in break up time (BUT)

Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.

Time frame: 8 weeks

Change in Visual Acuity

Change in Visual Acuity assessed before, during and after treatment period.

Time frame: 8 weeks

Change in tear osmolarity

Change in tear osmolarity assessed before, during and after treatment period.

Time frame: 8 weeks

Change in Staining of the cornea with fluorescein

Change in Staining of the cornea with fluorescein assessed before, during and after treatment period.

Time frame: 8 weeks

Change in impression cytology

Change in impression cytology assessed before, during and after treatment period.

Time frame: 8 weeks

Change in Schirmer I test

Change in Schirmer I test assessed before, during and after treatment period.

Time frame: 8 weeks

Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire) assessed before, during and after treatment period.

Time frame: 8 weeks

Change in intraocular pressure

Change in intraocular pressure assessed before, during and after treatment period.

Time frame: 8 weeks

Change in meibography

Change in meibography assessed before, during and after treatment period.

Time frame: 8 weeks

Change in conjuctival staining with lissamine green

Change in conjuctival staining with lissamine green assessed before, during and after treatment period.

Time frame: 8 weeks

Change in corneal sensitivity

Change in corneal sensitivity assessed before, during and after treatment period.

Time frame: 8 weeks

Change in signs and symptoms of meibomian gland disease (MGD)

Change in signs and symptoms of meibomian gland disease (MGD) assessed before, during and after treatment period.

Time frame: 8 weeks

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes