Safety and Efficacy of Moxidex Otic

Alcon

Status and phase: Terminated; Phase 3

Conditions: Acute Otitis Media

Treatments: Drug: Moxifloxacin otic solution; Drug: Moxidex otic solution; Device: Tympanostomy tubes; Other: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071902

C-09-033

Details and patient eligibility

About

The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.

Enrollment: 400 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6 months to 12 years of age
• Ear tubes in one or both ears
• Ear drainage visible by parent/guardian
• Ear drainage less than 21 days
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
• Ear tube with antimicrobial activity; ear tube longer than 2.5mm
• Non-tube otorrhea
• No otic surgery other than tube placement in the last year
• No menarchial females; no diabetic patients
• No patients with any disease or condition that would negatively affect the conduct of the study
• No patients taking any other systemic antimicrobial therapy during the study
• Patient must meet certain medication washouts to be eligible
• Analgesic use (other than acetaminophen) is not allowed
• Patients may not be predisposed to neurosensory hearing loss
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 3 patient groups, including a placebo group

Moxidex

Experimental group

Description:

Moxidex otic solution

Treatment:

Drug: Moxidex otic solution

Device: Tympanostomy tubes

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin otic solution

Treatment:

Device: Tympanostomy tubes

Drug: Moxifloxacin otic solution

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Device: Tympanostomy tubes

Other: Vehicle