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

Sponsor

Otic Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00872209

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis	Drug: 0.3% Ciprofloxacin Ear Drops Drug: 0.3% Ciprofloxacin Foam Otic Cipro	Phase 1/Phase 2

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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ciloxan Ear Drops Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops	Drug: 0.3% Ciprofloxacin Ear Drops 4 gtt BID for 7 days. Other Names: Ciloxan Ciprofloxacin Cipro
Experimental: Foam Otic Cipro Patients randomized to this study arm will receive the experimental product	Drug: 0.3% Ciprofloxacin Foam Otic Cipro 1 application, BID for 7 days Other Names: Ciloxan Ciprofloxacin Cipro

Arm

Intervention/Treatment

Active Comparator: Ciloxan Ear Drops

Ciloxan (Alcon, Inc.) Sterile Ophthalmic and Ear Drops

Drug: 0.3% Ciprofloxacin Ear Drops

4 gtt BID for 7 days.

Other Names:

Ciloxan

Ciprofloxacin

Cipro

Experimental: Foam Otic Cipro

Patients randomized to this study arm will receive the experimental product

Drug: 0.3% Ciprofloxacin Foam Otic Cipro

1 application, BID for 7 days

Other Names:

Ciloxan

Ciprofloxacin

Cipro

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	HaEmek Medical Center	Afula	Israel
2	Wolfson Medical Center	Holon	Israel	58100
3	Maccabi Healthcare Services	Tel Aviv	Israel	68125
4	Assaf Harofeh Medical Center	Zerifin	Israel	70300