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)
Overview
- Phase
- Phase 3
- Intervention
- Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution
- Conditions
- Acute Otitis Externa
- Sponsor
- Lee's Pharmaceutical Limited
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Clinical cure
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects with age of ≥3 years.
- •Subjects with clinical diagnosis of unilateral Acute Otitis Externa (AOE) within 21 days (3 weeks) prior to screening.
- •Subjects with graded II or III of AOE must experience each of symptoms or signs: as at least 2 for swelling (0-3 scale) and 1 for otorrhea (0-3 scale) and 2 for tenderness (0-3 scale).
- •Willingness to prevent water getting into the ear canal through end of the study (e.g. refrain from swimming, wear shower caps to cover the ears during showers).
- •For adult subjects, ability to fully understand the clinical trial and provide written informed consent. For subjects under the legal age (≥8 years and \<18 of age) and capable of giving informed consent, informed consent form sign by both the subject and the parent/legal guardian. For subjects under 8 years of age, signed consent form from the parent/legal guardian.
- •For females of childbearing potential (including partners of male subjects), not planning a pregnancy during the study and agree to use adequate birth control methods (from screening until 28 days after the final dose).
Exclusion Criteria
- •Subjects with bilateral AOE
- •Subjects who can't accept otoscopy (≤6 years of age) or oto-endoscope (\>6 years of age).
- •Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to enrollment.
- •Tympanic membrane perforation (including tympanostomy tubes).
- •Known or suspected of fungal or viral ear infections, cholesteatoma, otitis media, malignant otitis externa, mastoiditis, seborrheic dermatitis, neurodermatitis in the external ear canal, ear trauma or other non-infectious suppurative ear diseases.
- •Known or suspected of hearing loss.
- •History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiotherapy.
- •Current diagnosis of diabetes mellitus, psoriasis, immunodeficiency or history of drug abuse.
- •Current diagnosis of cardiovascular, respiratory, urinary, gastrointestinal and neurological diseases which require intervention after at least 4 weeks of drug therapy.
- •Use of any systemic antibacterial or topical antibiotic, corticosteroids, analgesic and anti-inflammatory drugs and other drug that affect the study results within 1 week prior to screening.
Arms & Interventions
ciprofloxacin 0.3% plus fluocinolone acetonide 0.025%
Warm the otic solution by holding the vial in the hands for 1 to 2 minutes. Twist off the vial cap. Tilt the subjects' head to one side to keep the affected ear up. Instill the content of 1 vial in the ear (0.25mL). Gently pull the outer ear lobe upward and outward to allow the solution to flow into the ear canal. Keep the subjects' head tilted sideways for approximately 5 minutes to allow the drug time to penetrate the ear. Use twice daily (every 12±1h , morning and evening) for 7 consecutive days.
Intervention: Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution
ciprofloxacin 0.3%
Warm the otic solution by holding the vial in the hands for 1 to 2 minutes. Twist off the vial cap. Tilt the subjects' head to one side to keep the affected ear up. Instill the content of 1 vial in the ear (0.25mL). Gently pull the outer ear lobe upward and outward to allow the solution to flow into the ear canal. Keep the subjects' head tilted sideways for approximately 5 minutes to allow the drug time to penetrate the ear. Use twice daily (every 12±1h, morning and evening) for 7 consecutive days
Intervention: Ciprofloxacin 0.3% solution
Outcomes
Primary Outcomes
Clinical cure
Time Frame: 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).
Secondary Outcomes
- change in each of Signs and Symptoms(8 and 15 days after first dose)
- Change in clinical improvement(8 and 15 days after first dose)
- Change in ear pain(8 and 15 days after first dose)
- Clinical cure(8 days after first dose)
- Change in Granulation Tissue(8 and 15 days after first dose)
- Microbiological cure(8 and 15 days after first dose)
- Overall therapeutic cure(8 and 15 days after first dose)
- Time to end of ear pain(8 and 15 days after first dose)