Dry Eye SyndromesPhase 4NCT03162497
Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction
A Phase 4 study testing Azithromycin and Doxycycline in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- What is being tested?
- Azithromycin and Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jan 2018to 23 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline
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.
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Being tested
- Azithromycin, Doxycycline
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Azithromycin 15mg/g eyedrops
DoxycyclineDrug
Doxycycline 100 mg per os
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Azithromycin |
| Doxycycline | Active comparator | Doxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tear film thickness
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.
Measured: 8 weeks
Secondary outcomes (13)
Change in lipid layer thickness
Change in lipid layer thickness measured with the Lipiview device before, during and after treatment period.
Measured: 8 weeks
Change in break up time (BUT)
Change in tear break up time (BUT) measured with fluorescein before, during and after treatment period.
Measured: 8 weeks
Change in Visual Acuity
Change in Visual Acuity assessed before, during and after treatment period.
Measured: 8 weeks
Change in tear osmolarity
Change in tear osmolarity assessed before, during and after treatment period.
Measured: 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.
Measured: 8 weeks
Change in impression cytology
Change in impression cytology assessed before, during and after treatment period.
Measured: 8 weeks
Change in Schirmer I test
Change in Schirmer I test assessed before, during and after treatment period.
Measured: 8 weeks
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.
Measured: 8 weeks
Change in intraocular pressure
Change in intraocular pressure assessed before, during and after treatment period.
Measured: 8 weeks
Change in meibography
Change in meibography assessed before, during and after treatment period.
Measured: 8 weeks
Change in conjuctival staining with lissamine green
Change in conjuctival staining with lissamine green assessed before, during and after treatment period.
Measured: 8 weeks
Change in corneal sensitivity
Change in corneal sensitivity assessed before, during and after treatment period.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start8 Jan 2018
- Primary completion9 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162497
- Sponsor's protocol ID
- OPHT-030815
- Status last verified
- Apr 2022
- First submitted
- 19 May 2017
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37327369
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction - Comparison to Oral Treatment With Doxycycline
- ClinicalTrials.gov ID
- NCT03162497
- Acronym / sponsor ID
- OPHT-030815
- Conditions
- Dry Eye Syndromes, Meibomian Gland Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: AzithromycinPreservative-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 | Drug: DoxycyclineDoxycycline 100mg (Doxycycline "Genericon", Genericon Pharma GmbH, Graz, Austria) twice daily for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAzithromycin 15mg/g eyedrops | Drug | Azithromycin |
| DoxycyclineDoxycycline 100 mg per os | Drug | Doxycycline |
Primary outcome
Change in tear film thickness
Time frame: 8 weeks
Change in tear film thickness measured with high resolution OCT before, during and after treatment period.
13 secondary outcomes
Change in lipid layer thickness
Time frame: 8 weeks
Change in break up time (BUT)
Time frame: 8 weeks
Change in Visual Acuity
Time frame: 8 weeks
Change in tear osmolarity
Time frame: 8 weeks
Change in Staining of the cornea with fluorescein
Time frame: 8 weeks
Change in impression cytology
Time frame: 8 weeks
Change in Schirmer I test
Time frame: 8 weeks
Change in Subjective symptoms of dry eye syndrome (OSDI© questionnaire)
Time frame: 8 weeks
Change in intraocular pressure
Time frame: 8 weeks
Change in meibography
Time frame: 8 weeks
Change in conjuctival staining with lissamine green
Time frame: 8 weeks
Change in corneal sensitivity
Time frame: 8 weeks
Change in signs and symptoms of meibomian gland disease (MGD)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 37327369Schlatter 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and Doxycycline in people with Dry Eye Syndromes and Meibomian Gland Dysfunction, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tear film thickness (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.