Status:
COMPLETED
Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
Lead Sponsor:
Otic Pharma
Conditions:
Otitis Externa
Otorhinolaryngologic Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin. The working hypothesis is th...
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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00872209
Start Date
May 1 2009
End Date
November 1 2009
Last Update
December 24 2009
Active Locations (4)
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1
HaEmek Medical Center
Afula, Israel
2
Wolfson Medical Center
Holon, Israel, 58100
3
Maccabi Healthcare Services
Tel Aviv, Israel, 68125
4
Assaf Harofeh Medical Center
Ẕerifin, Israel, 70300