Comparison of the efficacy of topical azithromycin with oral doxycycline in the treatment of meibomian gland dysfunction: A randomized clinical practice trial
To assess the efficacy of topical azithromycin drops versus oral doxycycline therapy in meibomian gland dysfuntion (MGD).
Design
Prospective, randomized, interventional, parallel group design with 60 patients, non-blinded to therapy, single center, clinical trial
Settings and conduct
The study patients were recruited from an EYE OPD between December 2019 to June 2020, at Qazi Hussain Ahmad Medical Complex, Nowshera. The groups were divided into two i.e. Topical Azithromycin 1% and Oral Doxycycline 100mg, groups were not blinded to therapy so as the examiners.
Participants/Inclusion and exclusion criteria
Inclusion criteria
All the patients within the specified age group with posterior blepharitis secondary to meibomian gland dysfunction
Patients with meibomian gland dysfunction, non responsive to conventional therapy such as lid massage, warm compresses and lid scrubbing
Exclusion criteria
En Patients with blepharitis other than posterior one
Patients with other inflammatory lid conditions like atopic blepharoconjunctivitis
Patients with traumatic eyelid injuries
Patients with neoplastic lid disorders
Pregnant, conceiving and lactating females
history of any allergy to the study drugs
Patients treated with oral or topical medications other than study drugs for posterior blepharitis within 3 months period
Intervention groups
1) Topical Azithromycin 1% twice daily for 1 week followed by once daily for 3 weeks
2) Oral Doxycycline 100 mg once daily for 4 weeks
Main outcome variables
1) Mean improvement in different symptoms score
2) Mean improvement in Schirmer 1 test
3) Mean improvement in Conjunctival hyperaemia
4) Mean improvement in Corneal staining score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220607055097N3
Registration date:2022-08-30, 1401/06/08
Registration timing:retrospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Adnan Ahmad
Name of organization / entity
Nowshera Medical College, Nowshera
Country
Pakistan
Phone
+92 91 2586506
Email address
dradnanahmad@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-01, 1398/09/10
Expected recruitment end date
2021-01-01, 1399/10/12
Actual recruitment start date
2020-01-01, 1398/10/11
Actual recruitment end date
2020-06-01, 1399/03/12
Trial completion date
2020-08-01, 1399/05/11
Scientific title
Comparison of the efficacy of topical azithromycin with oral doxycycline in the treatment of meibomian gland dysfunction: A randomized clinical practice trial
Public title
Topical Azithromycin and oral doxycycline in meibomian gland dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients within the specified age group with posterior blepharitis secondary to meibomian gland dysfunction
Patients with meibomian gland dysfunction, non responsive to conventional therapy such as lid massage, warm compresses and lid scrubbing
Exclusion criteria:
Patients with blepharitis other than posterior one
Patients with other inflammatory lid conditions like atopic blepharoconjunctivitis
Patients with traumatic eyelid injuries
Patients with neoplastic lid disorders
Pregnant, conceiving and lactating females
history of any allergy to the study drugs
Patients treated with oral or topical medications other than study drugs for posterior blepharitis within 3 months period
Age
From 26 years old to 42 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, unit of randomization taken as individual, non-stratified, Tools used in randomization was table of random numbers, allocation concealment was not carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Prospective, randomized clinical practice trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board of Nowshera Medical College
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
0432 /R&D/IERB/NMC
Health conditions studied
1
Description of health condition studied
Meibomian gland dysfunction
ICD-10 code
H01.0
ICD-10 code description
Blepharitis
Primary outcomes
1
Description
Mean improvement in symptoms score
Timepoint
Baseline, 2nd and 4th week
Method of measurement
Subjective symptoms including itchy eyes, grittiness, MG plugging, foreign body (FB) sensation and watering were recorded in a check list as 0 = asymptomatic, 1= moderate and 2 = severe symptoms
2
Description
Mean improvement in corneal staining
Timepoint
Baseline, 2nd and 4th week
Method of measurement
For corneal staining, we divided the cornea into five regions and assigned a score of 1 for peripheral staining and 4 for staining of central cornea implying more severe involvement by the disease process.
3
Description
Mean improvement in bulbar conjunctival hyperaemia
Timepoint
Baseline, 2nd and 4th week
Method of measurement
For bulbar conjunctival hyperaemia, area was divided into six regions and scoring from 0 to 4 was done depending upon the number of involved regions
4
Description
Mean improvement in Schirmer 1 test
Timepoint
Baseline, 2nd and 4th week
Method of measurement
Schemers 1 test (5 min. test without anesthesia) were performed in all of the participants, > 10 mm wetting was considered as normal.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical Azithromycin 1%, Twice daily for 1 week followed by once daily for 3 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Oral Doxycycline 100 mg, once daily for 4 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Full name of responsible person
Mubashir Rehman
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Phone
+92 923 9220325
Email
drmubashirrehman78@gmail.com
Web page address
https://nmcn.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Full name of responsible person
Nizam Darwesh
Street address
Mardan road, near Kabul river, Nowshera
City
Nowshera
Postal code
24110
Phone
+92 923 9223025
Email
info@nmcn.edu.pk
Web page address
https://nmcn.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nowshera Medical College/ Qazi Hussain Ahmad Medical Complex
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Nowshera Medical College, Nowshera
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Fax
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nowshera Medical College, Nowshera
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Fax
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Nowshera Medical College, Nowshera
Full name of responsible person
Adnan Ahmad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Civil colony
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25000
Phone
+92 91 2586506
Fax
Email
dradnanahmad@hotmail.com
Web page address
https://nmcn.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidential
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
It will be available when published and up to 1 year after publication
To whom data/document is available
For people working in academic institutions
Under which criteria data/document could be used
For research and academic purposes
From where data/document is obtainable
Via email upon request
What processes are involved for a request to access data/document