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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Pharmaceutical Solutions

Criteria

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