Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meib… (NCT06520007) | Clinical Trial Compass
CompletedNot Applicable
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction
Italy65 participantsStarted 2023-03-01
Plain-language summary
The goal of this observational study (spontaneous, non-randomised, prospective cohort, phase IV) is to compare the efficacy and safety of two different oral doxycycline treatment protocols (LCP - Low dose continuous protocol \& FPP - Full dose pulsed protocol) for meibomian gland dysfunction (MGD) in patients with refractory MGD (OSDI \> 13 after at least 2 months treatment with warm compresses and lacrimal substitutes - first-line therapy). Systemic doxycycline doesn't have a standardized treatment protocol and this is why those patients are treated as in normal clinical practice. The main questions it aims to answer are:
Which treatment protocol has a greater impact on patient symptoms during the follow-up (OSDI score reduction)? Which treatment protocol has a greater impact on patient signs during the follow-up (TBUT and corneal staining variations)? Which treatment protocol is safer (in terms of adverse events rate)?
Participants will be visited every 3 months (V0-V1-V2-V3) with signs and symptoms assessment (TBUT, corneal staining, OSDI score) after being treated for 3 months with the assigned doxycycline treatment protocol (LCP or FPP).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* 18 years or older
* Provided written informed consent
* OSDI score of 13 or more at the baseline visit after at least two months of first-line therapy (artificial tears and warm compresses)
* Clinical diagnosis of MGD
* Type 1 Schirmer test \> 10 mm
* No previous history of allergy or sensitivity to doxycycline,
* No use of additional topical or systemic antibiotics for the prior 2 months
* No use of topical anti-inflammatory agents (ex: corticosteroids or cyclosporine) for the prior 3 months.
Exclusion criteria
* Active ocular inflammation in either eye,
* Demodex blepharitis,
* Ocular surgery within the past 3 months of baseline examination,
* Structural ocular surface and eyelid abnormalities.
* Sjögren's syndrome
* Rheumatoid arthritis
* Other systemic diseases resulting in dry eye
* Known autoimmune disease
* Doxycycline allergy or sensitivity
* History of antibiotic therapy at any time within 2 months of the commencement of study
* Use of significant calcium supplementation or other medications that could interfere with doxycycline absorption (es: Iron supplementation)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
OSDI score
Timeframe: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)