Once-a-day: 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

Sponsor

Otic Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01157819

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

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 (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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Externa Otorhinolaryngologic Diseases Ear Diseases Otitis	Drug: 0.3% Ciprofloxacin Ear Drops Drug: FoamOtic Cipro	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. 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 :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Dec 1, 2010

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 b.i.d. for 7 days. Other Names: Ciloxan Ciprofloxacin Cipro
Experimental: Foam Otic Cipro Patients randomized to this study arm will receive the experimental product	Drug: FoamOtic Cipro 0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days Other Names: 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 b.i.d. for 7 days.

Other Names:

Ciloxan

Ciprofloxacin

Cipro

Experimental: Foam Otic Cipro

Patients randomized to this study arm will receive the experimental product

Drug: FoamOtic Cipro

0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days

Other Names:

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 that lasts 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.