Status:
COMPLETED
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
Lead Sponsor:
Otic Pharma
Conditions:
Otitis Externa
Otorhinolaryngologic Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
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 encou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01157819
Start Date
July 1 2010
End Date
December 1 2010
Last Update
March 15 2011
Active Locations (2)
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1
Wolfson Medical Center
Holon, Israel, 58100
2
Bet Roter Clinic, Clalit Health Services
Holon, Israel, 58320