Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT04636957
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT04636957
Study Brief:
Protocol Section:
NCT04636957