Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops … (NCT01359098) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
Israel100 participantsStarted 2011-07
Plain-language 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.
Who can participate
Age range3 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wi…
What they're measuring
1
Clinical cure [lack of need of additional therapy]
Timeframe: Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days