Clinical trial NCT01359098: Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otitis Externa
Otorhinolaryngologic Diseases
Ear Diseases
Otitis
Keywords: swimmer's ear
ear drops
ear foam
otic foam
ear infection
ear pain
ear inflammation
Lead sponsor: Otic Pharma
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Otalgia/ear pain
timeFrame: At Visit 1, [Day 1 ,Baseline visit], at Visit 2 [Day 3 - Day 4, during treatment] and at Visit 3 Test-of-cure [Day 8 to Day 14]
measure: Inflammation/ear edema
timeFrame: At the test-of-cure visit [Day 8 to Day 14]
measure: Ear discharge/otorrhea
timeFrame: At the test-of-cure visit [Day 8 to Day 14]
measure: tenderness with movement of pinna
timeFrame: At the test-of-cure visit [Day 8 - Day 14]
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Natania
country: Israel
facility: Clalit Health Services - Raziel Clinic
city: Tel Aviv
country: Israel
facility: Maccabi Healthcare Services (H.M.O.)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center (Ichilov)
Study officials:
affiliation: Edith Wolfson Medical Center
name: Yehudah Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: