Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis

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.
• •Bilateral Acute Otitis Externa.
• •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.