Clinical Study to Develop and Evaluate a New Combination Ear Drop for Reducing Pain and Inflammation in Patients with Inflammatory Ear Disorders

Development of a Novel ear drop formulation OTICRELIEF HC containing Hydrocortisone and Lignocaine for Inflammatory ear conditions - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104313

Enrollment

Registered

2026-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: H605- Acute noninfective otitis externa

Interventions

Intervention1: OTICRELIEF HC ear drops: OTICRELIEF HC ear drops containing hydrocortisone (1% w/v) and lignocaine (2% w/v) will be administered as 2 drops into the affected ear via the topical (aural)

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 65 years diagnosed with inflammatory ear conditions were recruited. (e.g., otitis externa without bacterial involvement, post-traumatic inflammation). No history of allergic reactions to hydrocortisone, lignocaine, or similar compounds. Patients willing to provide informed consent (or guardian consent for minors).

Exclusion criteria

Exclusion criteria: Chronic ear diseases Perforated tympanic membrane Known hypersensitivity to lignocaine or hydrocortisone Concurrent use of other ear medications that could confound the results.

Design outcomes

Primary

Measure	Time frame
A stable, Ph-balanced, and biocompatible ear drop formulation combining hydrocortisone and lignocaine provides rapid pain relief within minutes of application and reduces inflammation, swelling & itching within few days thus providing improved patient-reported outcomes (VAS pain scores, symptom resolution time). It will be a non-antibiotic alternative for mild-to-moderate otitis externa with comparable or superior efficacy to existing commercial formulations.Timepoint: Day 0 (Baseline): Pre-treatment assessment of symptoms and clinical findings. Day 0 (30 minutes after first application): Assessment of immediate analgesic effect. Day 5: Assessment of reduction in inflammatory signs and symptoms and evaluation of overall clinical improvement.	—

Measure

Time frame

A stable, Ph-balanced, and biocompatible ear drop formulation combining hydrocortisone and lignocaine provides rapid pain relief within minutes of application and reduces inflammation, swelling & itching within few days thus providing improved patient-reported outcomes (VAS pain scores, symptom resolution time). It will be a non-antibiotic alternative for mild-to-moderate otitis externa with comparable or superior efficacy to existing commercial formulations.Timepoint: Day 0 (Baseline): Pre-treatment assessment of symptoms and clinical findings. Day 0 (30 minutes after first application): Assessment of immediate analgesic effect. Day 5: Assessment of reduction in inflammatory signs and symptoms and evaluation of overall clinical improvement.

—

Secondary

Measure	Time frame
1.Change in VAS score at Day 3 & Day 7 2.Reduction in external auditory canal edema at Day 7 3.Resolution of otorrhea by Day 7 4.Time in days of complete resolution of symptom 5.Incidents of adverse events during 7-day follow upTimepoint: Day 7: Assessment of complete symptom resolution, external auditory canal edema, & recording of any adverse events.	—

Countries

India

Contacts

Public ContactBHURANI RITU

Saveetha Medical College and Hospital

shankarganesh2908@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026