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Completed

NCT Number: NCT03162497

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gerhard Garhofer

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

Azithromycin 15mg/g eyedrops

Doxycycline

Drug

Doxycycline 100 mg per os

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in Visual Acuity

    Time frame: 8 weeks

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

  4. Change in tear osmolarity

    Time frame: 8 weeks

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

  5. 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.

  6. Change in impression cytology

    Time frame: 8 weeks

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

  7. Change in Schirmer I test

    Time frame: 8 weeks

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

  8. 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.

  9. Change in intraocular pressure

    Time frame: 8 weeks

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

  10. Change in meibography

    Time frame: 8 weeks

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

  11. 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.

  12. Change in corneal sensitivity

    Time frame: 8 weeks

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

  13. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 22, 2017
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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