Effect of topical azithromycin on tear film thickness in patients with meibomian gland dysfunction – comparison to oral treatment with doxycycline

Phase 1

Conditions: Meibomian gland dysfunctionDry eye syndrome
MedDRA version: 20.0Level: PTClassification code 10065062Term: Meibomian gland dysfunctionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000014904
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2015-002508-94-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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
- Contraindicaton against the use of topical azithromycin or oral doxycycline

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of treatment with topical azithromycin or oral doxycycline on tear film thickness in patients with dry eye syndrome caused by meibomian gland dysfunction;Secondary Objective: To compare the effect of treatment with topical azithromycin or oral doxycycline in patients with dry eye syndrome caused by meibomian gland dysfunction on<br>- Lipid layer thickness<br>- Break up time (BUT)<br>- Visual Acuity<br>- Tear film osmolarity<br>- Staining of the cornea with fluorescein<br>- Impression cytology<br>- Schirmer I test<br>- Subjective symptoms of dry eye syndrome (OSDI© questionnaire)<br>- Intraocular pressure<br>- Meibography<br>- Conjuctival staining with lissamine green<br> - Corneal sensitivity<br>- Signs and symptoms of MGD;Primary end point(s): The primary endpoint will be the difference in tear film thickness between the two groups after treatment;Timepoint(s) of evaluation of this end point: 2, 4 and 6 weeks after start of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Difference between the two groups after treatment:<br><br>- Lipid layer thickness<br>- Break up time (BUT)<br>- Visual Acuity<br>- Tear film osmolarity<br>- Staining of the cornea with fluorescein<br>- Impression cytology<br>- Schirmer I test<br>- Subjective symptoms of dry eye syndrome (OSDI© questionnaire)<br>- Intraocular pressure<br>- Meibography<br>- Conjuctival staining with lissamine green<br> - Corneal sensitivity<br>- Signs and symptoms of MGD;Timepoint(s) of evaluation of this end point: 2, 4 and 6 weeks after start of treatment

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