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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otic Pharma
• Treatments: BB 1101; Ciprofloxacin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.