A Phase III, Multicenter, Randomized, Evaluator-blinded, Parallel-Group, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Externa (AOE)

NCT04636957 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Lee's Pharmaceutical Limited
Phase	Phase 3
Status	UNKNOWN
Enrolment	600
Start date	2020-11
Completion	2022-07

Conditions

• Acute Otitis Externa

Interventions

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

Primary outcomes

• Clinical cure — 15 days after first dose
  The proportion of patients who have all symptoms scored as 0. Treatment failure is defined as any symptoms scored \> 0. 1. Swelling: None(0), Mild(1), Moderate(2), Severe(3). 2. Otorrhea: None(0), Mild(1), Moderate(2), Severe(3). 3. Tenderness: None(0), Mild(1), Moderate(2), Severe(3).

Countries

China