Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction

NCT06520007 | Completed FDA Drug

• 1 other identifier: CPDOXY1
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Meibomian Gland Dysfunction; Blepharitis; Doxycycline Adverse Reaction

Keywords

Meibomian gland dysfunction; Ocular surface disease; Doxycycline; Blepharitis

Outcome Measures

Primary Outcomes (1)

• OSDI score

  Ocular Surface Disease Index

  Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)

Secondary Outcomes (3)

• TBUT

  Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)

• Corneal staining

  Baseline - 3 months (90 days ± 5 days) - 6 months (180 days ± 5 days)

• Adverse events

  From baseline up to the 3rd month

Study Arms (2)

LCP - Low dose continuous protocol

Assumption of 50 mg of oral doxycycline per day for 3 months

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

Drug: Doxycyclin

Interventions

Doxycyclin DRUG

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.

FPP - Full dose pulsed protocol; LCP - Low dose continuous protocol

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

ASST Santi Paolo e Carlo - Ospedale San Paolo

Milan, MI, 20142, Italy

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Blepharitis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 25, 2024
• Study Start: March 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)