Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes

PHASE3CompletedINTERVENTIONAL
Enrollment

776

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Acute Otitis Media
Interventions
DRUG

Moxidex otic solution

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

DRUG

Moxifloxacin otic solution

4 drops into the infected ear(s) twice daily (morning and evening) for 7 days

DEVICE

Tympanostomy tubes

Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alcon Research

INDUSTRY