Gerhard Garhofer
Vienna, State of Vienna, 1090, Austria
NCT Number: NCT03162497
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Vienna, State of Vienna, 1090, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Azithromycin 15mg/g eyedrops
Doxycycline 100 mg per os
Time frame: 8 weeks
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.
Time frame: 8 weeks
Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.
Time frame: 8 weeks
Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.
Time frame: 8 weeks
Change in Visual Acuity assessed before, during and after treatment period.
Time frame: 8 weeks
Change in tear osmolarity assessed before, during and after treatment period.
Time frame: 8 weeks
Change in Staining of the cornea with fluorescein assessed before, during and after treatment period.
Time frame: 8 weeks
Change in impression cytology assessed before, during and after treatment period.
Time frame: 8 weeks
Change in Schirmer I test assessed before, during and after treatment period.
Time frame: 8 weeks
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire) assessed before, during and after treatment period.
Time frame: 8 weeks
Change in intraocular pressure assessed before, during and after treatment period.
Time frame: 8 weeks
Change in meibography assessed before, during and after treatment period.
Time frame: 8 weeks
Change in conjuctival staining with lissamine green assessed before, during and after treatment period.
Time frame: 8 weeks
Change in corneal sensitivity assessed before, during and after treatment period.
Time frame: 8 weeks
Change in signs and symptoms of meibomian gland disease (MGD) assessed before, during and after treatment period.
Medical University of Vienna
Other
Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline
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