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

NCT03162497 | Completed Phase 4

• 1 other identifier: OPHT-030815
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in tear film thickness

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

  8 weeks

Secondary Outcomes (13)

• Change in lipid layer thickness

  8 weeks

• Change in break up time (BUT)

  8 weeks

• Change in Visual Acuity

  8 weeks

• Change in tear osmolarity

  8 weeks

• Change in Staining of the cornea with fluorescein

  8 weeks

Study Arms (2)

Azithromycin

EXPERIMENTAL

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

Doxycycline

ACTIVE COMPARATOR

Doxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks

Drug: Doxycycline

Interventions

Azithromycin DRUG

Azithromycin 15mg/g eyedrops

Azithromycin

Doxycycline DRUG

Doxycycline 100 mg per os

Doxycycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Gerhard Garhofer

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• Schlatter A, Hommer N, Kallab M, Stegmann H, Zeller K, Palkovits S, Findl O, Werkmeister RM, Schmetterer L, Garhofer G, Schmidl D. Effect of Treatment with Topical Azithromycin or Oral Doxycycline on Tear Film Thickness in Patients with Meibomian Gland Dysfunction: A Randomized Controlled Trial. J Ocul Pharmacol Ther. 2023 Jul;39(6):371-378. doi: 10.1089/jop.2022.0186. Epub 2023 Jun 16.

  PMID: 37327369 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Azithromycin; Doxycycline

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: January 8, 2018
• Primary Completion: September 9, 2022
• Study Completion: September 23, 2022
• Last Updated: May 23, 2025

Record last verified: 2022-04

Locations

AU (1)