Oral Azithromycin Versus Doxycycline in Posterior Blepharitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Study of the Effect of Oral Azithromycin on Posterior Blepharitis|
- Improvement of blepharitis [ Time Frame: Change from the baseline until 61 days after treatment ] [ Designated as safety issue: No ]Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment
- Main ocular signs [ Time Frame: Change from baseline until 61 days after treatment ] [ Designated as safety issue: No ]lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment
- The total clinical severity score [ Time Frame: Change from baseline until 61 days after treatment ] [ Designated as safety issue: No ]The total clinical severity score was calculated simply by adding total clinical symptoms and total clinical sings scores (range 0-36) in each visit. Furthermore, the patients' therapeutic at Baseline, and days 7, 31, 37 and 61 after treatment responses were classified according to the reduction of global severity score (symptoms score and signs score) as: excellent (76-100% reduction), good (51-75% reduction), fair (26-50% reduction), and poor (1-25% reduction) or even worse (less than 0%).
|Study Start Date:||January 2013|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Oral Azithromycin
Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.
Other Name: Azithromycin (Razak Co., Tehran)
Active Comparator: Doxycycline
Oral doxycycline 100mg capsule every 12 hours for one month
Other Name: Doxycycline (Kimidarou Co., Tehran)
|Iran, Islamic Republic of|
|Rassoul Akram Hospital|
|Tehran, Iran, Islamic Republic of, 14455-364|
|Study Director:||Mohsen B Kashkouli, MD||Tehran University of Medical Sciences|