Clinical trial NCT03162497: Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction
Official title: Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Meibomian Gland Dysfunction
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in tear film thickness
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in lipid layer thickness
timeFrame: 8 weeks
measure: Change in break up time (BUT)
timeFrame: 8 weeks
measure: Change in Visual Acuity
timeFrame: 8 weeks
measure: Change in tear osmolarity
timeFrame: 8 weeks
measure: Change in Staining of the cornea with fluorescein
timeFrame: 8 weeks
measure: Change in impression cytology
timeFrame: 8 weeks
measure: Change in Schirmer I test
timeFrame: 8 weeks
measure: Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)
timeFrame: 8 weeks
measure: Change in intraocular pressure
timeFrame: 8 weeks
measure: Change in meibography
timeFrame: 8 weeks
measure: Change in conjuctival staining with lissamine green
timeFrame: 8 weeks
measure: Change in corneal sensitivity
timeFrame: 8 weeks
measure: Change in signs and symptoms of meibomian gland disease (MGD)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Gerhard Garhofer
Study officials:
References: