Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
Information source: Otic Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis
Intervention: Ciprodex Otic Suspension (Drug); Ciprodexa Otic Foam (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Otic Pharma Official(s) and/or principal investigator(s): Yehudah Roth, MD, Principal Investigator, Affiliation: Edith Wolfson Medical Center
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.
Clinical Details
Official title: Safety and Efficacy of Once-Daily Dosing of Ciprodexa Otic Foam (Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Foam) Compared to Twice-Daily Dosing of Ciprodex (0.3% Ciprofloxacin and Dexamethasone 0.1% Otic Suspension) in Patients With Acute Otitis Externa
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical cure [lack of need of additional therapy]
Secondary outcome: Otalgia/ear painInflammation/ear edema Ear discharge/otorrhea tenderness with movement of pinna
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
(otorrhea).
Eligibility
Minimum age: 3 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
HaEmek Medical Center, Afula, Israel
Soroka Medical Center, Beer Sheva, Israel
Wolfson Medical Center, Holon 58100, Israel
Meir Medical Center, Kfar Saba, Israel
Clalit Health Services - Raziel Clinic, Natania, Israel
Maccabi Healthcare Services (H.M.O.), Tel Aviv, Israel
Sourasky Medical Center (Ichilov), Tel Aviv, Israel
Additional Information
Starting date: July 2011
Last updated: November 1, 2011
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