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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Doxycycline | Active Comparator | Doxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Azithromycin 15mg/g eyedrops |
| |
| Doxycycline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tear film thickness | Change in tear film thickness measured with high resolution OCT before, during and after treatment period. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid layer thickness | Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period. | 8 weeks |
| Change in break up time (BUT) | Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerhard Garhofer | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37327369 | Derived | 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. |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Drug |
Doxycycline 100 mg per os |
|
| 8 weeks |
| Change in Visual Acuity | Change in Visual Acuity assessed before, during and after treatment period. | 8 weeks |
| Change in tear osmolarity | Change in tear osmolarity assessed before, during and after treatment period. | 8 weeks |
| 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 |
| Change in impression cytology | Change in impression cytology assessed before, during and after treatment period. | 8 weeks |
| Change in Schirmer I test | Change in Schirmer I test assessed before, during and after treatment period. | 8 weeks |
| Change in Subjective symptoms of dry eye syndrome (OSDIĀ© questionnaire) | Change in Subjective symptoms of dry eye syndrome (OSDIĀ© questionnaire) assessed before, during and after treatment period. | 8 weeks |
| Change in intraocular pressure | Change in intraocular pressure assessed before, during and after treatment period. | 8 weeks |
| Change in meibography | Change in meibography assessed before, during and after treatment period. | 8 weeks |
| Change in conjuctival staining with lissamine green | Change in conjuctival staining with lissamine green assessed before, during and after treatment period. | 8 weeks |
| Change in corneal sensitivity | Change in corneal sensitivity assessed before, during and after treatment period. | 8 weeks |
| 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 |
| Organic Chemicals |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |