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

NCT ID: NCT01359098

Last Updated: 2011-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-11-30

Brief 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.

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 (otorrhea).

Conditions

Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprodex Otic Suspension

Ciprodex Sterile Otic Solution (Alcon, Inc.)

Group Type: ACTIVE_COMPARATOR

Ciprodex Otic Suspension

Intervention Type: DRUG

4 gtt b.i.d. for 7 days.

Ciprodexa Otic Foam

Ciprodexa Otic Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone otic foam)

Group Type: EXPERIMENTAL

Ciprodexa Otic Foam

Intervention Type: DRUG

0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days

Interventions

Ciprodex Otic Suspension

4 gtt b.i.d. for 7 days.

Intervention Type: DRUG

Ciprodexa Otic Foam

0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days

Intervention Type: DRUG

Other Intervention Names

Ciprodex; Ciprodex b.i.d.; Ciprofloxacin, Dexamethasone Otic Foam; Ciprodexa foam once-a-day

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otic Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehudah Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

Meir Medical Center

Kfar Saba, Israel, Israel

HaEmek Medical Center

Afula, , Israel

Soroka Medical Center

Beersheba, , Israel

Wolfson Medical Center

Holon, , Israel

Clalit Health Services - Raziel Clinic

Netanya, , Israel

Maccabi Healthcare Services (H.M.O.)

Tel Aviv, , Israel

Sourasky Medical Center (Ichilov)

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

OP-003-000

Identifier Type: -

Identifier Source: org_study_id