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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03162497
• Other study ID #: OPHT-030815
• Status: Recruiting
• Phase: Phase 4
• Start date: January 8, 2018
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: Gerhard Garhoefer, MD
• Phone: +43 1 40400
• Email: gerhard.garhoefer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Meibomian Gland Dysfunction

Intervention

Drug:
• Azithromycin
Azithromycin 15mg/g eyedrops
• Doxycycline
Doxycycline 100 mg per os

Locations

Country	Name	City	State
Austria	Gerhard Garhofer	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tear film thickness	Change in tear film thickness measured with high resolution OCT before, during and after treatment period.	8 weeks
Secondary	Change in lipid layer thickness	Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.	8 weeks
Secondary	Change in break up time (BUT)	Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.	8 weeks
Secondary	Change in Visual Acuity	Change in Visual Acuity assessed before, during and after treatment period.	8 weeks
Secondary	Change in tear osmolarity	Change in tear osmolarity assessed before, during and after treatment period.	8 weeks
Secondary	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
Secondary	Change in impression cytology	Change in impression cytology assessed before, during and after treatment period.	8 weeks
Secondary	Change in Schirmer I test	Change in Schirmer I test assessed before, during and after treatment period.	8 weeks
Secondary	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
Secondary	Change in intraocular pressure	Change in intraocular pressure assessed before, during and after treatment period.	8 weeks
Secondary	Change in meibography	Change in meibography assessed before, during and after treatment period.	8 weeks
Secondary	Change in conjuctival staining with lissamine green	Change in conjuctival staining with lissamine green assessed before, during and after treatment period.	8 weeks
Secondary	Change in corneal sensitivity	Change in corneal sensitivity assessed before, during and after treatment period.	8 weeks
Secondary	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