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

NCT ID: NCT03162497

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2022-09-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Azithromycin 15mg/g eyedrops

Doxycycline

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

Group Type: ACTIVE_COMPARATOR

Doxycycline

Intervention Type: DRUG

Doxycycline 100 mg per os

Interventions

Azithromycin

Azithromycin 15mg/g eyedrops

Intervention Type: DRUG

Doxycycline

Doxycycline 100 mg per os

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gerhard Garhofer

Assoc. Prof. PD Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gerhard Garhofer

Vienna, Vienna, Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 37327369 (View on PubMed)

Other Identifiers

OPHT-030815

Identifier Type: -

Identifier Source: org_study_id