Clinical Trial: Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of the Effect of Oral Azithromycin on Posterior Blepharitis

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.

Detailed Summary:
Sponsor: Tehran University of Medical Sciences

Current Primary Outcome:

• Change of Blepharitis Symptoms Score [ Time Frame: Change from the baseline until 61 days after treatment ]
  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. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.
• Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score [ Time Frame: zero time and 61 days later ]
  Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.

Original Primary Outcome: Improvement of blepharitis [ Time Frame: Change from the baseline until 61 days after treatment ]

Current Secondary Outcome: Main Ocular Signs [ Time Frame: Change from baseline until 61 days after treatment ]

Original Secondary Outcome: Main Ocular Signs [ Time Frame: Change from baseline until 61 days after treatment ]

Dates:
Date Received: February 1, 2013
Date Started: January 2013
Date Completion:
Last Updated: December 28, 2013
Last Verified: December 2013