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

Seoul National University Hospital15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hearing Loss, Sudden Hearing Loss, Ototoxic Hearing Loss, Noise-Induced Meniere Disease

Interventions

DexamethasoneDRUG

Dexamethasone 5mg/ml

Hyaluronic acidDRUG

Hyaluronic Acid 20mg/2ml

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Verification of tympanic membrane with endoscopy (Safety)

Confirming healing time of perforation and inflammation

Time frame: 3-4 weeks after intratympanic injection

Confirmation of inflammation and drug with CT imaging (Durability)

Checking a time duration of drug in middle and inner ear

Time frame: 1 day and/or 1 weeks after intratympanic injection

Valuation of hearing threshold with Pure tone audiometry (Efficacy)

Verifying therapeutic effect of intratympanic drug delivery vehicle

Time frame: 3-4 weeks after intratympanic injection

Data from ClinicalTrials.gov

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