Abstract
Purpose: :
To evaluate the efficacy of 4-week treatment with azithromycin ophthalmic solution 1.0% in reducing the eyelid margin bacterial load, tear cytokines, and the signs and symptoms of blepharitis in patients with moderate to severe chronic blepharitis.
Methods: :
Eight-week multi-center, open-label clinical study in chronic blepharitis patients. The use of eyelid scrubs or mechanical therapy was not permitted during the study. Patients instilled azithromycin ophthalmic solution 1% BID on days 1 and 2 and QD on days 3-28. Tear samples for cytokine analysis and eyelid margin bacterial cultures were collected at baseline and after 4 weeks of treatment. Bacteria were identified by genus and species when possible and colony counts were graded on a 0-4 scale. Tear samples were evaluated for cytokine concentrations using Luminex multiplex immunobead assay. The severity of the blepharitis signs and symptoms was assessed on a 0-3 or 0-4 ORA blepharitis scale.
Results: :
Twenty-six patients were enrolled and twenty-three completed the study. Eyelid margin cultures exhibited significant decreases in coagulase-negative staphylococci (p=0.037) and Corynebacterium xerosis (p<0.001) bacteria. Complete bacterial results for all species will be provided in the poster. Tear cytokine concentrations did not appear to be affected by azithromycin treatment. Median scores for all symptoms (eyelid itching, foreign body sensation/sandiness/grittiness, ocular dryness, ocular burning/pain and swollen eyelids) were significantly decreased from baseline upon treatment completion after 4 weeks of treatment (p<0.001). Median scores for the clinical signs of blepharitis including: eyelid margin redness, palpebral conjunctival redness and meibomian gland plugging were significantly reduced after 4 weeks of treatment (p<0.001 to p=0.008).
Conclusions: :
Treatment with topical azithromycin ophthalmic solution 1% resulted in a significant reduction in the most common eyelid bacterial flora and provided significant improvement in both signs and symptoms of blepharitis.
Clinical Trial: :
www.clinicaltrials.gov NCT00629941
Keywords: antibiotics/antifungals/antiparasitics • cornea: tears/tear film/dry eye