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

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

Conditions
-----------------
Acute Otitis Externa

Intervention / Treatment
-----------------
* Drug: Moxidex otic solution
* Drug: Moxifloxacin otic solution
* Drug: Dexamethasone phosphate otic solution
* Device: Tympanostomy tubes


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxidex<br>Moxidex otic solution | Drug: Moxidex otic solution<br>* 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days<br>Device: Tympanostomy tubes<br>* Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children<br>|
| Active Comparator: Moxifloxacin<br>Moxifloxacin otic solution | Drug: Moxifloxacin otic solution<br>* 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days<br>Device: Tympanostomy tubes<br>* Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children<br>|
| Active Comparator: Dexamethasone<br>Dexamethasone phosphate otic solution | Drug: Dexamethasone phosphate otic solution<br>* 4 drops in the infected ear(s) twice daily (morning and evening) for 7 days<br>Device: Tympanostomy tubes<br>* Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure |  | Day 3 | 
| Clinical Cure |  | Day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Success |  | Day 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ear infection, ear pain, ear inflammation, swimmer's ear, ear drops