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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 990

Inclusion Criteria

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

Exclusion Criteria

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
Use of prohibited medications or inadequate washout of any medication listed in protocol
Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial
Other protocol-defined exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moxidex	Moxidex otic solution	Moxidex otic solution
Moxidex	Tympanostomy tubes	Moxidex otic solution
Moxifloxacin	Moxifloxacin otic solution	Moxifloxacin otic solution
Moxifloxacin	Tympanostomy tubes	Moxifloxacin otic solution
Dexamethasone	Dexamethasone phosphate otic solution	Dexamethasone phosphate otic solution
Dexamethasone	Tympanostomy tubes	Dexamethasone phosphate otic solution