A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea

Alcon

Status and phase: Completed; Phase 2

Conditions: Acute Otitis Media

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578773

C-05-38

Details and patient eligibility

About

The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.

Enrollment: 303 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6 months to 12 years old
• Diagnosed with recurrent acute otitis media or chronic otitis media with effusion
• Must be first set of ear tubes.
• Patient may not have had any other previous otologic-related surgery.
• Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
• Patient may not have existing perforation of the eardrum.
• Patient must not require another surgical procedure other than myringotomy and tube insertion.
• Patient may not be a menarchal female
• Diabetic patients are not eligible
• Patient may not have any disease or condition that would negatively affect the conduct of the study
• Patient may not require 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
• Patient may not be pre-disposed to neurosensory hearing loss
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Age
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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303 participants in 3 patient groups

Moxidex

Experimental group

Description:

Moxidex otic solution

Treatment:

Device: Tympanostomy tubes

Drug: Moxidex otic solution

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin otic solution

Treatment:

Device: Tympanostomy tubes

Drug: Moxifloxacin otic solution

TT only

Other group

Description:

Tympanostomy tubes only

Treatment:

Device: Tympanostomy tubes