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Phase 2 N=100 Randomized Double-blind Treatment

Oral Azithromycin Versus Doxycycline in Posterior Blepharitis

Posterior Blepharitis

Enrolled (actual)
100
Serious AEs
15.0%
Results posted
Feb 2014
Primary outcome: Primary: Change of Blepharitis Symptoms Score — 1.8; 2.8 score — p=0.03

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Azithromycin (Drug); Doxycycline (Drug)
Age
Pediatric, Adult, Older Adult · 13+ yrs
Sex
All
Sponsor
Tehran University of Medical Sciences
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change of Blepharitis Symptoms Score
1.8; 2.8 0.03 sig
PRIMARY
Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score
6.5; 8.6 0.007 sig
SECONDARY
Main Ocular Signs
4.7; 5.7 0.01 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01783860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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