A Phase III Study of an Otic Formulation in Acute Otitis Externa

PHASE3CompletedINTERVENTIONAL
Enrollment

990

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Acute Otitis Externa
Interventions
DRUG

Moxidex otic solution

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

DRUG

Moxifloxacin otic solution

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

DRUG

Dexamethasone phosphate otic solution

4 drops in 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 with effusion in children

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alcon Research

INDUSTRY

NCT00750633 - A Phase III Study of an Otic Formulation in Acute Otitis Externa | Biotech Hunter | Biotech Hunter