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

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline

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 Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction
• Intervention / Treatment: Drug: Azithromycin; Drug: Doxycycline

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Gerhard Garhofer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azithromycin; Preservative-free azithromycin 15mg/g (Azyter® Augentropfen im Einzeldosisbehältnis, Thea, Clermont-Ferrand, France) one drop twice daily for two days then once daily for 26 days	Drug: Azithromycin; Azithromycin 15mg/g eyedrops
Active Comparator: Doxycycline; Doxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks	Drug: Doxycycline; Doxycycline 100 mg per os

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tear film thickness	Change in tear film thickness measured with high resolution OCT before, during and after treatment period.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lipid layer thickness	Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.	8 weeks
Change in break up time (BUT)	Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.	8 weeks
Change in Visual Acuity	Change in Visual Acuity assessed before, during and after treatment period.	8 weeks
Change in tear osmolarity	Change in tear osmolarity assessed before, during and after treatment period.	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.	8 weeks
Change in impression cytology	Change in impression cytology assessed before, during and after treatment period.	8 weeks
Change in Schirmer I test	Change in Schirmer I test assessed before, during and after treatment period.	8 weeks
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)	Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire) assessed before, during and after treatment period.	8 weeks
Change in intraocular pressure	Change in intraocular pressure assessed before, during and after treatment period.	8 weeks
Change in meibography	Change in meibography assessed before, during and after treatment period.	8 weeks
Change in conjuctival staining with lissamine green	Change in conjuctival staining with lissamine green assessed before, during and after treatment period.	8 weeks
Change in corneal sensitivity	Change in corneal sensitivity assessed before, during and after treatment period.	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.	8 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Dry Eye Syndromes; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Doxycycline; Azithromycin
• Other Study ID Numbers: OPHT-030815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No