To assess the effect of antibiotic eye drops (azithromycin) on the signs and symptoms of dry eyes (Meibomian gland dysfunction)
| ISRCTN | ISRCTN13717543 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13717543 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 269433 |
| Protocol serial number | IRAS 269433 |
| Sponsor | University of Dundee |
| Funder | School of Nursing and Health Sciences, University of Dundee |
- Submission date
- 03/06/2023
- Registration date
- 22/06/2023
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
One important factor affecting the quality of tears is the Meibomian glands' function. These are tiny glands located along the edges of the eyelids that produce an oily substance called meibum. This meibum helps to lubricate the surface of the eyes, prevent tear evaporation, and maintain the stability of the tear film. The modern lifestyle, which often involves spending time indoors with air conditioning and central heating, can have a noticeable impact on tear quality. Optometrists are well positioned to manage a condition called Meibomian gland dysfunction (MGD) within the community. In the UK, there has been an increase in Independent Prescribing Optometrists, with 500 registered with the General Optical Council. This allows practitioners to have more options for prescribing when treating MGD.
There are various treatment options available for MGD. However, patient compliance is a significant factor in determining the success of treatment, especially in chronic conditions. Research has shown that patients with long-term dry eye problems tend to have reduced compliance with lid hygiene. Finding a treatment that can break the cycle of dryness, inflammation, and keratinization of the Meibomian glands, and reduce the need for long-term management of MGD, could potentially improve the patient's quality of life and reduce the financial burden on the National Health Service, which currently supplies lubricants for ongoing treatment. The annual cost of managing dry eye disease was estimated to be around £570 per person per year in the UK.
Topical Azithromycin has been identified as a viable treatment option comparable to oral doxycycline. Research has found that it was as effective as doxycycline in restoring low levels of carotenoids typically found in MGD, thus improving tear film stability.
This study aims to analyze the effectiveness of topical azithromycin in reducing signs and symptoms of MGD, as well as the need for self-treatment methods, in a community Optometry practice in the UK.
Who can participate?
Patients with persistent Meibomian gland dysfunction (MGD) and previous treatment of lid hygiene, lubricants, heat & massage had been ineffective at relieving signs or symptoms.
What does the study involve?
The study involved patients to consent to the treatment and then to complete a post-treatment survey one year on.
What are the possible benefits and risks of participating?
Benefits, reduced symptoms and effect on lifestyle from MGD.
Risks are low, possible hypersensitivity to the drug.
Where is the study run from?
Jarvis Optometrist, a community Optometry practice (UK)
When is the study starting and how long is it expected to run for?
March 2026 to July 2020
Who is funding the study?
This study is self-funded, with research assistance from the College of Optometrists (UK)
Who is the main contact?
Ian Jarvis, ian.jarvis2@nhs.scot
Contact information
Public
24-26 Arbroath Road
Dundee
DD4 6EP
United Kingdom
 ORCID ID |
0000-0002-7428-8233 |
|---|---|
| Phone | +44 1382462236 |
| ian.jarvis2@nhs.scot |
Scientific
24-26 Arbroath Road
Dundee
DD4 6EP
United Kingdom
| Phone | +44 1382462236 |
|---|---|
| ian.jarvis2@nhs.scot |
Principal investigator
24-26 Arbroath Road
Dundee
DD4 6EP
United Kingdom
| Phone | +44 1382462236 |
|---|---|
| ian.jarvis2@nhs.scot |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional non randomized study |
| Secondary study design | Non randomised study |
| Participant information sheet | 43754 PIS TAMS v1.1 19Sep2019.pdf |
| Scientific title | The Topical Azithromycin Meibomian Gland Dysfunction Survey (TAMS): the effect of topical azithromycin on signs and symptoms of Meibomian gland dysfunction |
| Study acronym | TAMS |
| Study objectives | The use of topical azithromycin reduces signs, symptoms and self-management of Meibomian gland dysfunction |
| Ethics approval(s) | Approved 01/10/2019, Wales Ethical Approval Committee 7 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 2922 940968; Wales.REC7@wales.nhs.uk), ref: 19/WA/0253 |
| Health condition(s) or problem(s) studied | Meibomian gland dysfunction |
| Intervention | This study was conducted in a community Optometry practice over a 2 year period (2016-2018). Patients were invited to participate in the study, who had persistent Meibomian gland dysfunction (MGD) and previous treatment of lid hygiene, lubricants, heat & massage had been ineffective at relieving signs or symptoms. The first 40 suitable patients were invited to take part in the study, to minimise selection bias.There were no general health exclusions that needed to be applied. The treatment involved taking one drop of topical azithromycin, 15mg/g (Thea pharmaceuticals) twice daily for 2 weeks and then once a day for the following two weeks. After treatment, objective data was collected from the participant record |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Topical azithromycin, 15mg/g eye drops |
| Primary outcome measure(s) |
1. Meibomian gland dysfunction (MGD) measured using the Efron grading scale before and after treatment |
| Key secondary outcome measure(s) |
Long-term benefit of treatment on symptoms and self-treatment methods, by post-treatment survey one year on from treatment. In brief, the survey asked the participants how their management of MGD had changed, which dry eye symptoms they had pre- and post-treatment (sensitivity to light, gritty/ burning sensation and blurred vision). They were also asked to what extent their symptoms affected their lifestyle, (reading, night driving, computer use and watching television) and how they were affected by environmental conditions (windy, dry and air-conditioned environments). This used a combination of yes/no responses and a numerical grading of symptoms of 1-5, where 1= least affected and 5=most affected. |
| Completion date | 27/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 39 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 31 |
| Key inclusion criteria | This study was conducted in a community Optometry practice over a 2 year period (2016-2018). Patients were invited to participate in the study, who had persistent Meibomian gland dysfunction (MGD) and previous treatment of lid hygiene, lubricants, heat & massage had been ineffective at relieving signs or symptoms. |
| Key exclusion criteria | 1. No Meibomian gland dysfunction 2. Managed Meibomian gland dysfunction |
| Date of first enrolment | 02/10/2019 |
| Date of final enrolment | 13/01/2020 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Dundee
DD4 6EP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during the study will be available on request from Ian Jarvis: ian.jarvis2@nhs.scot |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/05/2024 | 12/09/2024 | Yes | No | |
| Participant information sheet | version 1.1 | 19/09/2019 | 16/06/2023 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1 | 12/05/2019 | 16/06/2023 | No | No |
Additional files
- 43754 PIS TAMS v1.1 19Sep2019.pdf
- Participant information sheet
- 43754 Protocol v1 12May2019.pdf
- Protocol file
Editorial Notes
12/09/2024: Publication reference added.
24/05/2024: The intention to publish date was changed from 01/09/2023 to 01/07/2024.
16/06/2023: Trial's existence confirmed by Tayside Medical Science Centre.
