Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520007
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Continuous and Pulsed Oral Doxycycline Treatment Protocols for Refractory Meibomian Gland Dysfunction - 9 Months Follow-up Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 doesnt 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
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None