A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)
Not yet recruiting
Lee's Pharmaceutical Limited
Phase 3
2020-11-01
This is a phase Ⅲ, multicenter, randomized, evaluator-blinded, parallel-group,
active-controlled study to assess the efficacy and safety of ciprofloxacin 0.3% plus
fluocinolone acetonide 0.025% otic solution vs ciprofloxacin 0.3% otic solution in the
treatment of AOE, and to assess the pharmacokinetic properties in 12 selected adult subjects.
Eligible subjects will be randomized at 1:1 ration to either the treatment arm or control
arm. All subject will receive 7 consecutive days of either ciprofloxacin 0.3% plus
fluocinolone acetonide 0.025% otic solution or ciprofloxacin 0.3% otic solution alone. The
main objectives are to assess the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone
acetonide 0.025% otic solution in the treatment of AOE, and to assess the plasma
concentration of ciprofloxacin and fluocinolone acetonide after multiple doses of test drug
in 12 adult subjects, and evaluate the PK parameters.
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