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Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

Primary Purpose

Dry Eye Syndromes, Meibomian Gland Dysfunction

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Azithromycin
Doxycycline
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gerhard GarhoferRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azithromycin

Doxycycline

Arm Description

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 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks

Outcomes

Primary Outcome Measures

Change in tear film thickness
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.

Secondary Outcome Measures

Change in lipid layer thickness
Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.
Change in break up time (BUT)
Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.
Change in Visual Acuity
Change in Visual Acuity assessed before, during and after treatment period.
Change in tear osmolarity
Change in tear osmolarity assessed before, during and after treatment period.
Change in Staining of the cornea with fluorescein
Change in Staining of the cornea with fluorescein assessed before, during and after treatment period.
Change in impression cytology
Change in impression cytology assessed before, during and after treatment period.
Change in Schirmer I test
Change in Schirmer I test assessed before, during and after treatment period.
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire) assessed before, during and after treatment period.
Change in intraocular pressure
Change in intraocular pressure assessed before, during and after treatment period.
Change in meibography
Change in meibography assessed before, during and after treatment period.
Change in conjuctival staining with lissamine green
Change in conjuctival staining with lissamine green assessed before, during and after treatment period.
Change in corneal sensitivity
Change in corneal sensitivity assessed before, during and after treatment period.
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.

Full Information

First Posted
May 19, 2017
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03162497
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
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
Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Doxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin 15mg/g eyedrops
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Doxycycline 100 mg per os
Primary Outcome Measure Information:
Title
Change in tear film thickness
Description
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in lipid layer thickness
Description
Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.
Time Frame
8 weeks
Title
Change in break up time (BUT)
Description
Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.
Time Frame
8 weeks
Title
Change in Visual Acuity
Description
Change in Visual Acuity assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in tear osmolarity
Description
Change in tear osmolarity assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in Staining of the cornea with fluorescein
Description
Change in Staining of the cornea with fluorescein assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in impression cytology
Description
Change in impression cytology assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in Schirmer I test
Description
Change in Schirmer I test assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)
Description
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire) assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in intraocular pressure
Description
Change in intraocular pressure assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in meibography
Description
Change in meibography assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in conjuctival staining with lissamine green
Description
Change in conjuctival staining with lissamine green assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in corneal sensitivity
Description
Change in corneal sensitivity assessed before, during and after treatment period.
Time Frame
8 weeks
Title
Change in signs and symptoms of meibomian gland disease (MGD)
Description
Change in signs and symptoms of meibomian gland disease (MGD) assessed before, during and after treatment period.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhoefer, MD
Phone
+43 1 40400
Ext
29810
Email
gerhard.garhoefer@meduniwien.ac.at
Facility Information:
Facility Name
Gerhard Garhofer
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhofer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Gerhard Garhofer, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

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