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

Otitis externa (OE) is an inflammatory condition of the external auditory canal, often presenting with pain, itching, and swelling. While it may be infective (bacterial or fungal), several non-infective causes include swimmer’s ear, eczematous dermatitis (ex atopic or seborrheic), neurodermatitis, trauma from cotton bud use, and radiation-induced inflammation. While antibiotic-steroid combination ear drops are being commonly prescribed for otitis externa, many cases of non-infective OE do not require anti-microbial therapy.

Thus in non-infective OE, anti-inflammatory and analgesic therapy is often more appropriate. Hydrocortisone, a corticosteroid, effectively reduces inflammation, itching, and swelling, while Lignocaine, a local anesthetic, provides prompt pain relief. Hydrocortisone and lignocaine combination drops are well-tolerated with minimal side effects when used appropriately and are less likely to cause allergic reactions. Hence, developing a novel ear drop combining hydrocortisone and lignocaine (OTICRELIEF HC) offers a targeted, safer, and patient-friendly alternative to conventional antibiotic-steroid ear drops. It provides symptom relief while addressing the growing need for rational antibiotic use in otology avoiding resistance and preserving the normal ear flora.

This study is a prospective, randomized, controlled clinical trial designed to evaluate the efficacy and safety of a combination otic solution containing Hydrocortisone and Lignocaine (OTICRELIEF HC) in patients with non-inflammatory otitis externa. A total of 50 participants will be randomized in a 1:1 ratio to receive either OTICRELIEF HC or control treatment. The outcomes are assessed by reduction in ear pain severity measured using the Visual Analog Scale (VAS), resolution of external auditory canal edema and otorrhea by clinical otoscopic examination, requirement of rescue analgesics, and incidence of adverse events. Participants will be followed up for a total period of 7 days (Follow-up logs are maintained for Day 0, Day 3-5, Day 7) to assess clinical response and safety.