Meibomian Gland DysfunctionNCT06520007
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction
An observational study of Meibomian Gland Dysfunction and Blepharitis, run by University of Milan at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Meibomian Gland Dysfunction, Blepharitis, Doxycycline Adverse Reaction
- What is being tested?
- Doxycyclin
- Type of treatment
- Pill or oral medicine
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 1 May 2024
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory meibomian gland dysfunction (MGD). Refractory MGD is defined as symptomatic MGD (OSDI > 13 points) despite 2 months of first-line treatment with lacrimal substitutes 3 times per day and meibomian gland expression with warm compresses twice per day.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction - 9 Months Follow-up Prospective Study
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).
Read the detailed description
This spontaneous, prospective, non-randomized, parallel-group, phase IV study was conducted in compliance with the tenets of the Declaration of Helsinki.
All study participants were fully consented, and written informed consent was obtained.
This study included patients with refractory MGD. Refractory MGD is defined as symptomatic MGC (OSDI > 13 points) despite 2 months of first-line treatment with lacrimal substitutes 3 times per day and meibomian gland expression with warm compresses twice per day.
The study will consist of 3 visits: Baseline (day 0), Visit 2 (day 90 ± 5 - 3rd month), Visit 3 (day 180 ± 5 - 6 month). At each visit, patients will receive an OSDI questionnaire, NIBUT, type I Schirmer test and AS assessment, including TBUT, corneal staining (Oxford scale) At baseline, eligible patients will be enrolled and treated with the assigned protocol. The investigators will assign the protocol (non-randomized) in a 1:1 ratio.
At Visit 2, NIBUT, TBUT, Oxford scale and OSDI improvement will be evaluated compared with Visit 1. Patients will be carefully asked about their compliance with the treatment. Patients who interrupted the treatment for adverse events or low compliance (<75% of the protocol adherence) will exit the study and be excluded from the analysis.
At Visit 3, the study population will be evaluated as done in Visit 2
The protocols in the study are the following:
LCD (low-dose continuous protocol) - 50 mg of doxycycline for three months FPP ( Full-dose pulsed protocol) - 100 mg of doxycycline for the first 15 days of the month for three months.
The enrollment period will last about 6 months. Therefore, the study will end about 6 months after the last patient enrols.
- Being tested
- Doxycyclin
- Keywords
- Meibomian gland dysfunction, Ocular surface disease, Doxycycline, Blepharitis
- Medical subject headings
- Meibomian Gland Dysfunction, Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclinDrug
The drug has been prescribed, as in normal clinical practice, with the National Healthcare System. Patients have been fully informed about interactions, toxicity and posology schedule.
| Study group | Role | What they receive |
|---|---|---|
| LCP - Low dose continuous protocol | Assumption of 50 mg of oral doxycycline per day for 3 months Receives: Drug: Doxycyclin | |
| FPP - Full dose pulsed protocol | Assumption of 100 mg of oral doxycycline per day for 15 days per month (with a subsequent 15 days of washout) for 3 months Receives: Drug: Doxycyclin |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI score
Ocular Surface Disease Index
Measured: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Secondary outcomes (3)
TBUT
Tear break-up time
Measured: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Corneal staining
Oxford scale has been use to assess corneal staining
Measured: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Adverse events
Number of dropouts due to drug toxicity
Measured: From baseline up to the 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Mar 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fogagnolo, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520007
- Sponsor's protocol ID
- CPDOXY1
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction - 9 Months Follow-up Prospective Study
- ClinicalTrials.gov ID
- NCT06520007
- Acronym / sponsor ID
- CPDOXY1
- Keywords
- Meibomian gland dysfunction, Ocular surface disease, Doxycycline, Blepharitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 25 Jul 2024 (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.
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).
Detailed description
This spontaneous, prospective, non-randomized, parallel-group, phase IV study was conducted in compliance with the tenets of the Declaration of Helsinki.
All study participants were fully consented, and written informed consent was obtained.
This study included patients with refractory MGD. Refractory MGD is defined as symptomatic MGC (OSDI > 13 points) despite 2 months of first-line treatment with lacrimal substitutes 3 times per day and meibomian gland expression with warm compresses twice per day.
The study will consist of 3 visits: Baseline (day 0), Visit 2 (day 90 ± 5 - 3rd month), Visit 3 (day 180 ± 5 - 6 month). At each visit, patients will receive an OSDI questionnaire, NIBUT, type I Schirmer test and AS assessment, including TBUT, corneal staining (Oxford scale) At baseline, eligible patients will be enrolled and treated with the assigned protocol. The investigators will assign the protocol (non-randomized) in a 1:1 ratio.
At Visit 2, NIBUT, TBUT, Oxford scale and OSDI improvement will be evaluated compared with Visit 1. Patients will be carefully asked about their compliance with the treatment. Patients who interrupted the treatment for adverse events or low compliance (<75% of the protocol adherence) will exit the study and be excluded from the analysis.
At Visit 3, the study population will be evaluated as done in Visit 2
The protocols in the study are the following:
LCD (low-dose continuous protocol) - 50 mg of doxycycline for three months FPP ( Full-dose pulsed protocol) - 100 mg of doxycycline for the first 15 days of the month for three months.
The enrollment period will last about 6 months. Therefore, the study will end about 6 months after the last patient enrols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCP - Low dose continuous protocol | – | Drug: DoxycyclinAssumption of 50 mg of oral doxycycline per day for 3 months |
| FPP - Full dose pulsed protocol | – | Drug: DoxycyclinAssumption of 100 mg of oral doxycycline per day for 15 days per month (with a subsequent 15 days of washout) for 3 months |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory meibomian gland dysfunction (MGD). Refractory MGD is defined as symptomatic MGD (OSDI > 13 points) despite 2 months of first-line treatment with lacrimal substitutes 3 times per day and meibomian gland expression with warm compresses twice per day.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| DoxycyclinThe drug has been prescribed, as in normal clinical practice, with the National Healthcare System. Patients have been fully informed about interactions, toxicity and posology schedule. | Drug | FPP - Full dose pulsed protocol, LCP - Low dose continuous protocol |
Primary outcome
OSDI score
Time frame: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Ocular Surface Disease Index
3 secondary outcomes
TBUT
Time frame: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Corneal staining
Time frame: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)
Adverse events
Time frame: From baseline up to the 3rd month
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 25 Jul 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Meibomian Gland Dysfunction and Blepharitis, run by University of Milan at 1 site in Italy.
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 8 inclusion and 11 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 25 Jul 2024. 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 Italy. 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.
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?
OSDI score (time frame: Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.