Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro (0.3% Ciprofloxacin Otic Foam) Compared to Twice-Daily Dosing of Ciloxan (0.3% Ciprofloxacin Otic Solution) in Patients With Acute External Otitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
Study Overview
Brief Summary
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro (0.3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops used twice daily for 7 days.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 and older eligible to sign by themselves.
- •Have a clinical diagnosis of Acute Otitis Externa based on clinical observation and of presumed bacterial origin.
- •Intact tympanic membrane
- •Unilateral Acute Otitis Externa
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.
Arms & Interventions
Ciloxan Ear Drops
Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops
Intervention: 0.3% Ciprofloxacin Ear Drops (Drug)
Foam Otic Cipro
Patients randomized to this study arm will receive the experimental product
Intervention: FoamOtic Cipro (Drug)
Outcomes
Primary Outcomes
Clinical cure confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion
Time Frame: within 7 days after completion of treatment that lasts 7 days
Secondary Outcomes
No secondary outcomes reported