Clinical Research Directory

Inclusion Criteria: 1. Male or female subjects with age of ≥3 years. 2. Diagnosis of unilateral or bilateral diffuse acute otitis externa (AOE) within 21 days (3 weeks) before screening. 3. Grade II or III AOE, with at least Grade 2 edema (ear canal swelling), at least Grade 2 ear tenderness (pain on palpation), and at least Grade 1 otorrhea present concurrently. 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 unable to undergo otoscopy or otoendoscopy. 2. An episode of AOE 21 to 28 days before screening, or 2 or more episodes of AOE 21 to 180 days before screening. 3. Tympanic membrane perforation (including tympanostomy tubes). 4. 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. 5. Children aged 6 years or younger with an abnormal result on audiological assessment using behavioral audiometry, multi-frequency auditory steady-state response (ASSR), auditory brainstem response (ABR), distortion product otoacoustic emissions (DPOAE), play audiometry, or another non-pure-tone audiometric method. 6. History of malignant tumors in the external ear canal, or currently receiving chemotherapy or radiotherapy. 7. Current diagnosis of diabetes mellitus, psoriasis, immunodeficiency or history of drug abuse. 8. A severe cardiovascular, respiratory, urinary, digestive, or nervous system disease that remains unstable after at least 4 weeks of pharmacotherapy and requires additional intervention. 9. Use within 1 week before screening of any systemic or topical antimicrobial agent, corticosteroid, anti-inflammatory or analgesic medication, or any other medication that could affect evaluation of the study results, when the interval between the last dose and screening was less than 6 half-lives of the medication. 10. Known or suspected hypersensitivity to quinolones, corticosteroid or any component of the study medication. 11. Participation in another clinical trial within the previous 3 months. 12. Pregnant women or nursing mothers. 13. Any condition that, in the judgment of the principal investigator, render the subject not suitable for the study.