Meibomian gland dysfunction Dry eye syndrome MedDRA version: 20.0 Level: PT Classification code 10065062 Term: Meibomian gland dysfunction System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000014904
Conditions
Interventions
Trade Name: Azyter 15 mg/g Augentropfen im Einzeldosisbehältnis
Product Name: Azyter
Pharmaceutical Form: Eye drops
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Other descriptive name: AZITHROMYCIN DIH
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Lipid layer thickness - Break up time (BUT) - Visual Acuity - Tear film osmolarity - Staining of the cornea with fluorescein - Impression cytology - Schirmer I test - Subjective symptoms of dry eye syndrome (OSDI© questionnaire) - Intraocular pressure - Meibography - Conjuctival staining with lissamine green - Corneal sensitivity - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between the two groups after treatment: - Lipid layer thickness - Break up time (BUT) - Visual Acuity - Tear film osmolarity - Staining of the cornea with fluorescein - Impression cytology - Schirmer I test - Subjective symptoms of dry eye syndrome (OSDI© questionnaire) - Intraocular pressure - Meibography - Conjuctival staining with lissamine green - Corneal sensitivity - Signs and symptoms of MGD;Timepoint(s) of evaluation of this end point: 2, 4 and 6 weeks after start of treatment | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmacology
Medical University of Vienna
Outcome results
None listed