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

May 20, 2025 updated by: Gerhard Garhofer, Medical University of Vienna

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Gerhard Garhofer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in tear film thickness
Time Frame: 8 weeks
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in lipid layer thickness
Time Frame: 8 weeks
Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.
8 weeks
Change in break up time (BUT)
Time Frame: 8 weeks
Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.
8 weeks
Change in Visual Acuity
Time Frame: 8 weeks
Change in Visual Acuity assessed before, during and after treatment period.
8 weeks
Change in tear osmolarity
Time Frame: 8 weeks
Change in tear osmolarity assessed before, during and after treatment period.
8 weeks
Change in Staining of the cornea with fluorescein
Time Frame: 8 weeks
Change in Staining of the cornea with fluorescein assessed before, during and after treatment period.
8 weeks
Change in impression cytology
Time Frame: 8 weeks
Change in impression cytology assessed before, during and after treatment period.
8 weeks
Change in Schirmer I test
Time Frame: 8 weeks
Change in Schirmer I test assessed before, during and after treatment period.
8 weeks
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)
Time Frame: 8 weeks
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire) assessed before, during and after treatment period.
8 weeks
Change in intraocular pressure
Time Frame: 8 weeks
Change in intraocular pressure assessed before, during and after treatment period.
8 weeks
Change in meibography
Time Frame: 8 weeks
Change in meibography assessed before, during and after treatment period.
8 weeks
Change in conjuctival staining with lissamine green
Time Frame: 8 weeks
Change in conjuctival staining with lissamine green assessed before, during and after treatment period.
8 weeks
Change in corneal sensitivity
Time Frame: 8 weeks
Change in corneal sensitivity assessed before, during and after treatment period.
8 weeks
Change in signs and symptoms of meibomian gland disease (MGD)
Time Frame: 8 weeks
Change in signs and symptoms of meibomian gland disease (MGD) assessed before, during and after treatment period.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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