A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)

PHASE3UnknownINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

December 31, 2021

Study Completion Date

July 31, 2022

Conditions
Acute Otitis Externa
Interventions
DRUG

Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution

0.25mL/vial, each vial contains 0.75mg of ciprofloxacin and 0.0625mg of fluocinolone acetonide.

DRUG

Ciprofloxacin 0.3% solution

0.4mL/vial, each vial contains 1.2mg ciprofloxacin

Trial Locations (1)

200031

Eye & Ent Hospital of Fudan University, Shanghai

Sponsors
All Listed Sponsors
lead

Lee's Pharmaceutical Limited

INDUSTRY