Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

Safety and Efficacy of Once-Daily Dosing of Ciprodexa Otic Foam (Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Foam) Compared to Twice-Daily Dosing of Ciprodex (0.3% Ciprofloxacin and Dexamethasone 0.1% Otic Suspension) in Patients With Acute Otitis Externa

The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.

Acute otitis externa (AOE) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. AOE is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. Diagnosis of AOE requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: A) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; B) tenderness of the tragus and/or pinna; and C) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge (otorrhea).

Inclusion Criteria:

• Aged 3 years to 80 years old.
• Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
• Intact tympanic membrane
• Unilateral disease

Exclusion Criteria:

• Known allergy or sensitivity to Ciprofloxacin or other quinolones.
• Clinical Diagnosis of chronic suppurative otitis media (CSOM), acute otitis media (AOM), involvement of middle ear effusion (MEE).
• Patient has the non intact tympanic membrane.
• Patient has a serious underlying disease.
• Patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy.
• Patients with history of Diabetes mellitus.
• Patients with more than 80% of the ear canal occluded.
• Pregnant or lactating patients.
• Overt fungal Acute Otitis Externa.
• Local ear canal abnormalities such as abscess, granulation or polyps.
• Congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear.
• Mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear.
• Seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation.
• Current Infection requiring systemic antimicrobial therapy.
• Current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days).
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.