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

Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04766853

Enrollment

Registered

2021-02-23

Start date

2021-07-22

Completion date

2024-07-19

Last updated

2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hearing loss, Drug Delivery, Dexamethasone, Hyaluronic Acid, Intratympanic injection

Brief summary

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.

Interventions

DRUGDexamethasone

Dexamethasone 5mg/ml

DRUGHyaluronic acid

Hyaluronic Acid 20mg/2ml

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Verification of tympanic membrane with endoscopy (Safety)	3-4 weeks after intratympanic injection	Confirming healing time of perforation and inflammation
Confirmation of inflammation and drug with CT imaging (Durability)	1 day and/or 1 weeks after intratympanic injection	Checking a time duration of drug in middle and inner ear
Valuation of hearing threshold with Pure tone audiometry (Efficacy)	3-4 weeks after intratympanic injection	Verifying therapeutic effect of intratympanic drug delivery vehicle

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026