Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

Otorhinolaryngologic Diseases Clinical Trial

— Ciprodexa Foam  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359098
• Other study ID #: OP-003-000
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2011
• Last updated: November 1, 2011
• Start date: July 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Otic Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ear Diseases
• Otitis
• Otitis Externa
• Otorhinolaryngologic Diseases

Intervention

Drug:
• Ciprodex Otic Suspension
4 gtt b.i.d. for 7 days.
• Ciprodexa Otic Foam
0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula
Israel	Soroka Medical Center	Beer Sheva
Israel	Wolfson Medical Center	Holon
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

Sponsors (1)

Lead Sponsor	Collaborator
Otic Pharma

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure [lack of need of additional therapy]	Clinical cure [lack of need of additional therapy] confirmed by significant reduction or absence of the disease symptoms a) Otalgia/ear pain, b) tenderness with movement of pinna, c) edema/ear canal occlusion and d) ear discharge/otorrhea	Between Day 8 and Day 14 [e.g. 7 days after completion of treatment] that lasts 7 days	No
Secondary	Otalgia/ear pain	Ear pain as reported by the patient	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]	No
Secondary	Inflammation/ear edema		At the test-of-cure visit [Day 8 to Day 14]	No
Secondary	Ear discharge/otorrhea		At the test-of-cure visit [Day 8 to Day 14]	No
Secondary	tenderness with movement of pinna		At the test-of-cure visit [Day 8 - Day 14]	No