Acute Otitis Externa
Conditions
Interventions
Ofloxacin and dexamethasone treatment group:None
Ofloxacin treatment group:None
Sponsors
Eye & ENT Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: • Male or female patients aged >= 3 years; • Diagnosed with diffuse acute otitis externa (AOE) within 21 days; • AOE severity graded II-III, with subjects presenting at least concurrent grade 2 swelling, grade 2 ear tenderness, and grade 1 exudate; • Agreement to implement measures preventing water ingress into the ear canal during the study period (e.g., refraining from swimming, wearing shower caps covering both ears while bathing); • Subjects must fully comprehend the trial content and voluntarily provide signed informed consent, or have previously signed the "Informed Consent Form for Donors of Biological Samples and Health-Related Information," or qualify for waived informed consent requirements.
Exclusion criteria
Exclusion criteria: • Patients with bilateral AOE • Those unable to undergo otoscopic examination • Patients with recurrent AOE (=2 episodes within 3 weeks) • Individuals with tympanic membrane perforation, including those with tympanostomy tubes • Known or suspected fungal/viral ear infections, cholesteatoma, otitis media, malignant otitis externa, mastoiditis, seborrheic dermatitis of the external ear, neurodermatitis of the external ear, ear trauma, or other non-infectious suppurative ear conditions • Subjects with known or suspected hearing abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Otic Symptom Score;Clinical cure rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score; | — |
Countries
China
Contacts
Public ContactYan Jingchao
Eye & ENT Hospital, Fudan University
Outcome results
None listed