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

PHASE3CompletedINTERVENTIONAL
Enrollment

911

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

August 31, 2008

Study Completion Date

August 31, 2008

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

Ofloxacin otic solution

5 drops into the infected ear(s) twice daily (morning and evening) for 10 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