Status:
COMPLETED
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction
Lead Sponsor:
University of Milan
Conditions:
Meibomian Gland Dysfunction
Blepharitis
Eligibility:
All Genders
18-100 years
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 ...
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, ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06520007
Start Date
March 1 2023
End Date
May 1 2024
Last Update
July 25 2024
Active Locations (1)
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1
ASST Santi Paolo e Carlo - Ospedale San Paolo
Milan, MI, Italy, 20142