Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

Seoul National University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Meniere Disease; Hearing Loss, Sudden; Hearing Loss, Noise-Induced; Hearing Loss, Ototoxic

Treatments: Drug: Dexamethasone; Drug: Hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04766853

H-1812-128-997

Details and patient eligibility

About

This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.

Enrollment: 15 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
• Patients whose hearing has not been restored after standard treatment
• Patients do not participate in clinical trials within 6 months

Exclusion criteria

• Patients with retrocochlear lesion
• Patients with history of hypersensitivity to the ingredients of this drug
• Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Dexamethasone+Saline

Active Comparator group

Treatment:

Drug: Dexamethasone

Dexamethasone+Hyaluronic Acid

Experimental group

Treatment:

Drug: Hyaluronic acid

Drug: Dexamethasone