A Phase III Study of an Otic Formulation in Acute Otitis Externa

Alcon Research0 sites990 target enrollmentJune 2008

Overview

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

January 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
•A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema
•Other protocol-defined inclusion criteria may apply

•Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
•Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
•Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
•Known or suspected ear infection of fungal or mycobacterial origin
•Prior otologic surgery within 6 months of study entry
•Seborrheic dermatitis or other skin conditions of the external auditory canal
•Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
•Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
•Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction\]
•Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy