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

Alcon

Status and phase: Completed; Phase 3

Conditions: Acute Otitis Externa

Treatments: Drug: Dexamethasone phosphate otic solution; Drug: Moxifloxacin otic solution; Device: Tympanostomy tubes; Drug: Moxidex otic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750633

C-07-13

Details and patient eligibility

About

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

Enrollment: 990 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

990 participants in 3 patient groups

Moxidex

Experimental group

Description:

Moxidex otic solution

Treatment:

Drug: Moxidex otic solution

Device: Tympanostomy tubes

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin otic solution

Treatment:

Drug: Moxifloxacin otic solution

Device: Tympanostomy tubes

Dexamethasone

Active Comparator group

Description:

Dexamethasone phosphate otic solution

Treatment:

Drug: Dexamethasone phosphate otic solution

Device: Tympanostomy tubes