Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis

Otorhinolaryngologic Diseases Clinical Trial

— Once-a-day  

Official title:

Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro (0.3% Ciprofloxacin Otic Foam) Compared to Twice-Daily Dosing of Ciloxan (0.3% Ciprofloxacin Otic Solution) in Patients With Acute External Otitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157819
• Other study ID #: OP-002-000
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2010
• Last updated: March 14, 2011
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: March 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 Foam Otic Cipro (0.3% Ciprofloxacin Otic Foam), used once-daily for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to commercial ear drops 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 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.

• 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.

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:
• 0.3% Ciprofloxacin Ear Drops
4 gtt b.i.d. for 7 days.
• FoamOtic Cipro
0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days

Locations

Country	Name	City	State
Israel	Bet Roter Clinic, Clalit Health Services	Holon
Israel	Wolfson Medical Center	Holon

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 confirmed by significant reduction or absence of the disease symptoms a) Otalgia, b) tenderness with movement of pinna, and c) edema/ear canal occlusion		within 7 days after completion of treatment that lasts 7 days	No