Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa

Otorhinolaryngologic Diseases Clinical Trial

Official title:

Bioequivalence of Ciprofloxacin 0.3%: a Randomized, Multicenter, Parallel, Comparative Study on the Safety and Efficacy of Ciprofloxacin 0.3% in a Standard Solution or Foam Solution, in Patients With Acute External Otitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872209
• Other study ID #: OP-001-00
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 29, 2009
• Last updated: December 23, 2009
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• 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, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin.

The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.

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. The reported annual incidence of AOE is between 1:100 and 1:250 in the general population with large seasonal and regional variations. 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: 100
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• 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 BID for 7 days.
• 0.3% Ciprofloxacin Foam Otic Cipro
1 application, BID for 7 days

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula
Israel	Wolfson Medical Center	Holon
Israel	Maccabi Healthcare Services	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zerifin

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 (BID, for 7 days)	No