comparative efficacy and safety of ciprofloxacin 0.3% and dexamethasone 0.1% in acute otitis externa

Conditions: Acute Otitis Externa

Summary: the purpose of the study is to demonstrate the clinical therapeutic non-inferiority of exl cdos to commercially available ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension (ciprodex®, alcon) in the treatment of acute otitis externa (aoe) when administered twice daily for 7 days.

this was a phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of aoe with a 2-day screening period followed by a 2-week participation period. subjects were administered study drug, exl cdos or rld, 4 drops in the affected ear(s) bid for 7 days. the primary endpoint, the proportion of subjects with a clinical aoe score of 0, was measured at the toc visit on day 15.

Eligibility criteria:
inclusion criteria: 1. male or female, 6 months of age and over; 2. clinically documented aoe consistent with the diagnostic guidelines of the american academy of otolaryngology-head and neck surgery foundation in 1 or both ears; 3. inflammation and/or edema ≥2 on the aoe scale, and otorrhea and/or tenderness present; 4. aoe of \<4 weeks duration; 5. intact tympanic membrane(s) in the treated ear(s); 6. willingness to refrain from swimming through the toc/ visit 5; 7. for subjects with aoe associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the toc/visit 5; 8. ability to complete the study in compliance with the protocol; 9. for adult subjects, ability to understand and provide written informed consent; and 10. for pediatric subjects, a parent or legal guardian has provided written informed consent; and 11. for children age 6 and above, ability to understand and provide assent according to institutional requirements. exclusion criteria: 1. acute or chronic suppurative otitis media; 2. post-tympanostomy tube acute otorrhea; 3. malignant otitis externa; 4. suspected or overt fungal or viral ear infection; 5. congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s); 6. seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation; 7. mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s); 8. malignant tumors of the external auditory canal of the treated ear(s); 9. history of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery \>6 months prior to baseline; 10. four or more episodes of otitis externa (oe) in the previous year; 11. uncontrolled diabetes mellitus; 12. immunosuppressive disorder, including known human immunodeficiency virus infection; 13. renal insufficiency; 14. hepatitis or hepatic insufficiency; 15. receipt of systemic antibiotic concurrently or within 72 hours prior to baseline; 16. receipt of topical otic antibiotic within 24 hours prior to baseline; 17. use of systemic corticosteroid concurrently or within 30 days prior to baseline; 18. use of topical otic corticosteroids concurrently or within 7 days prior to baseline; 19. concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs; 20. use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to baseline; 21. pregnancy, planned pregnancy, or lactation; 22. known sensitivity or intolerance to quinolone antibacterial agents; 23. previous participation in this trial; 24. participation in another investigational drug or vaccine trial concurrently or within 30 days; or 25. significant acute or chronic medical, neurologic, or psychiatric illness in the subject or parent/guardian that, in the judgment of the principal investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.