Clinical trial NCT04636957: A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Otitis Externa
Keywords: ciprofloxacin
fluocinolone acetonide 0.025%
AOE
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects with age of ≥3 years.
2. Subjects with clinical diagnosis of unilateral Acute Otitis Externa (AOE) within 21 days (3 weeks) prior to screening.
3. 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).
4. 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).
5. 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.
6. 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:

1. Subjects with bilateral AOE
2. Subjects who can't accept otoscopy (≤6 years of age) or oto-endoscope (\>6 years of age).
3. Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to enrollment.
4. Tympanic membrane perforation (including tympanostomy tubes).
5. 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.
6. Known or suspected of hearing loss.
7. History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiotherapy.
8. Current diagnosis of diabetes mellitus, psoriasis, immunodeficiency or history of drug abuse.
9. Current diagnosis of cardiovascular, respiratory, urinary, gastrointestinal and neurological diseases which require intervention after at least 4 weeks of drug therapy.
10. 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.
11. Known or suspected hypersensitivity to quinolones, corticosteroid or any component of the study medication.
12. Participation in another clinical trial within the previous 3 months.
13. Pregnant women or nursing mothers.
14. Any condition that, in the judgment of the principal investigator, render the subject not suitable for the study.

Primary outcomes:
measure: Clinical cure
timeFrame: 15 days after first dose
Secondary outcomes:
measure: Microbiological cure
timeFrame: 8 and 15 days after first dose
measure: Overall therapeutic cure
timeFrame: 8 and 15 days after first dose
measure: Clinical cure
timeFrame: 8 days after first dose
measure: Change in clinical improvement
timeFrame: 8 and 15 days after first dose
measure: change in each of Signs and Symptoms
timeFrame: 8 and 15 days after first dose
measure: Change in Granulation Tissue
timeFrame: 8 and 15 days after first dose
measure: Change in ear pain
timeFrame: 8 and 15 days after first dose
measure: Time to end of ear pain
timeFrame: 8 and 15 days after first dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & Ent Hospital of Fudan University
Study officials:
References: