Clinical trial NCT01783860: Oral Azithromycin Versus Doxycycline in Posterior Blepharitis
Official title: Study of the Effect of Oral Azithromycin on Posterior Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posterior Blepharitis
Keywords: Azithromycin
Doxycycline
Posterior Blepharitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One hundred patients with the diagnosis of posterior blepharitis based on history taking and proper physical examinations by two experienced ophthalmologists will include in the study.

Patients will diagnose with posterior blepharitis if they score at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria. Patients will exclude if they have the following criteria: age\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines.

Qualified patients then randomly receive oral azithromycin (2 of 250 mg capsules for the first day and 250mg for the next 4 days) or oral doxycycline (100mg capsule every 12 hours for one month) in a double-blinded fashion. each patients in both treatment groups will accurately instruct to apply warm compress and eyelid scrubbing 2 times a day for 5 minutes each in the treatment period. Symptoms and signs were recorded for each patient in two treatment groups at baseline visit (before treatment) and then in the days 7, 31, 37 and 61 after treatment.


Eligibility criteria: Inclusion Criteria:

Patients were diagnosed with posterior blepharitis if they scored at least one in two symptoms (based on a subjective grading scale) and two signs (based on an objective grading scale) of posterior blepharitis according to study criteria

Exclusion Criteria:

Patients were excluded if they had the following criteria: age\< 12 years old,history of previous ocular or lacrimal surgery,previous usage of contact lenses,any history of ocular allergy,history of systemic diseases with ocular involvement (except rosacea), history of usage of topical or systemic antibiotic in the last month, pregnancy or lactating mothers, liver failure and any history of sensitivity to cyclines

Primary outcomes:
measure: Change of Blepharitis Symptoms Score
timeFrame: Change from the baseline until 61 days after treatment
measure: Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score
timeFrame: zero time and 61 days later
Secondary outcomes:
measure: Main Ocular Signs
timeFrame: Change from baseline until 61 days after treatment
Other outcomes:
measure: Change of Total Severity Score Between Baseline and 7 Days Later
timeFrame: baseline and 7 days later
measure: Change of Total Severity Score Between Baseline and 31 Days Later
timeFrame: baseline and 31 days later
measure: Change of Total Severity Score Between Baseline and 37 Days Later
timeFrame: baseline and 37 days later
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rassoul Akram Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohsen B Kashkouli, MD
role: STUDY_DIRECTOR
References:
citation: Kashkouli MB, Fazel AJ, Kiavash V, Nojomi M, Ghiasian L. Oral azithromycin versus doxycycline in meibomian gland dysfunction: a randomised double-masked open-label clinical trial. Br J Ophthalmol. 2015 Feb;99(2):199-204. doi: 10.1136/bjophthalmol-2014-305410. Epub 2014 Aug 19.