Efficacy of ofloxacin otic solution once daily for 7 days in the treatment of otitis externa: a multicenter, open-label, phase III trial

Clinical Therapeutics
Benjamin TorumElyane Lombardy

Abstract

Otitis externa (OE) is an infection of the external auditory canal that is typically treated with topically applied broad-spectrum antibiotics. Twice-daily topical treatment with ofloxacin otic 0.3% solution for 10 days has been reported to be as effective and well tolerated as the standard of care, neomycin sulfate/polymyxin B sulfate/hydrocortisone solution administered 4 times daily for 10 days. This study evaluated the efficacy and safety profile of 7 days of a once-daily regimen of ofloxacin otic 0.3% solution in the treatment of OE. This multicenter, open-label, Phase III study was conducted from June 12, 2002, to October 14, 2002. Eligible patients were aged > or = 6 months and had OE of <2 weeks' duration with moderate to severe edema and tenderness involving 1 or both ears and sufficient exudate for microbiologic culture. Ofloxacin otic solution was instilled once daily for 7 days (5 drops for children aged 6 months to <13 years, 10 drops for adolescents/adults aged > or = 13 years). Assessments were conducted at the end-of-treatment visit and 7 to 10 days later (the test-of-cure visit). Medication was supplied free of charge to study participants who incurred no costs for physician visits. Of 489 patients enrolled at ...Continue Reading

References

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Citations

Apr 28, 2006·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Richard M RosenfeldUNKNOWN American Academy of Otolaryngology--Head and Neck Surgery Foundation
Apr 23, 2013·Emergency Medicine Clinics of North America·Keith Conover
Jan 8, 2014·Pharmaceutical Development and Technology·Samer AdwanAlsayyed Sallam
Feb 5, 2014·Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery·Richard M RosenfeldPeter J Robertson
Jan 22, 2010·The Cochrane Database of Systematic Reviews·Vivek KaushikShakeel R Saeed
Feb 14, 2006·Current Opinion in Pediatrics·Mark R Schleiss
Feb 14, 2006·Current Opinion in Pediatrics·Kathryn Edwards, David M Freeman

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