April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Antimicrobial Efficacy of Azithromycin/Dexamethasone Combination in Blepharoconjunctivitis Patients, a Phase 3 Study
Author Affiliations & Notes
  • E. C. Si
    Pre-Clinical Research,
    InSite Vision Inc, Alameda, California
  • J. Hutcheson
    Clinical Research,
    InSite Vision Inc, Alameda, California
  • K. Hosseini
    Clinical Affairs,
    InSite Vision Inc, Alameda, California
  • Footnotes
    Commercial Relationships  E.C. Si, InSite Vision, E; J. Hutcheson, InSite Vision, E; K. Hosseini, InSite Vision, E.
  • Footnotes
    Support  InSite Vision
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 2888. doi:
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      E. C. Si, J. Hutcheson, K. Hosseini; Antimicrobial Efficacy of Azithromycin/Dexamethasone Combination in Blepharoconjunctivitis Patients, a Phase 3 Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2888.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : To evaluate the antimicrobial effect of a combination product containing azithromycin and dexamethasone and its individual components, azithromycin and dexamethasone, on the bacterial flora of blepharoconjunctivitis patients.

Methods: : In a double-blind, phase 3 study, subjects with blepharoconjunctivitis were randomized to receive either 1% azithromycin/0.1% dexamethasone (AzaSite Plus), 1% azithromycin (AzaSite), or 0.1% dexamethasone ophthalmic formulation. All 3 formulations were formulated in DuraSite®, a topical polymeric drug delivery system. Each patient received two drops of formulation, one at the cul-de-sac, and the other on the eyelid, twice daily for 14 days. Baseline cul-de-sac and eyelid cultures were taken on the first day, before any treatment.

Results: : There were 417 subjects enrolled in the study; 140 in the AzaSite Plus group, 141 in the AzaSite group, and 136 in the Dexamethasone group. The overall culture-positive rate in the cul-de-sac and the eyelid across the three groups was 34% and 67%, respectively. Twenty-eight percent of the subjects had sterile ocular surfaces. The bacterial flora in the two tissues was overwhelmingly Gram positive, being 95% and 96%, respectively. Staphylococcus aureus and Staphylococcus epidermidis were the 2 predominant species inhabiting the two tissues, being 16% and 50% for cul-de-sac, respectively; and 18% and 71% for eyelid, respectively. At the end of the 14-day treatment period, the bacterial eradication rates for both cul-de-sac and eyelid in the AzaSite Plus, AzaSite, and dexamethasone groups were 60%, 66%, and 40% (p<0.007), respectively.

Conclusions: : The azithromycin/dexamethasone combination in DuraSite significantly eradicated bacteria in the ocular tissues after 14 days of treatment. The addition of dexamethasone to azithromycin did not significantly diminish its anti-microbial activities.

Clinical Trial: : www.clinicaltrials.gov NCT00578955

Keywords: bacterial disease • eyelid • conjunctivitis 

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