Safety and Efficacy of the combination of Naphazoline Hydrochloride, Hydroxy Propyl Methyl Cellulose, Boric acid, Borax, Menthol and Camphor in patients of Ocular allergy and Ocular inflammation of a non-infectious origin

Abstract

Objective: Ocular allergy is an inflammatory response by an allergen when it interacts with IgE bound mast cells. Ocular redness, ocular itching and ocular discharge are the main symptoms. Naphazoline is ocular decongestant used for the treatment of ocular redness. Hydroxy Propyl Methyl Cellulose (HPMC) moistens, soothes and lubricates the ocular surface. Boric acid and Borax are Anti-inflammatory/mild Anti-infective while Menthol and Camphor are used to give soothing effect to the eye.

Methods: Of 216 patients, 205 patients completed the study. 11 patients were lost to follow-up. Efficacy assessment was done by studying the reduction in Visual Analogue Scale (VAS) of ocular redness, itching and discharge at day 3 and day 5 as compared to baseline. Safety assessment was made by analysing the adverse events during the clinical trial.

Results: Mean VAS score of ocular redness, ocular discharge and ocular itching was 4.71, 3.07 and 4.22 (baseline) at visit 1 respectively which was slightly  reduced to 2.33, 1.45 and 2.12 (day 3)at visit 2 respectively and it was further reduced to 1.07, 0.83 and 0.65 (day 5) at visit 3respectively.

Conclusion: Combination of Naphazoline, HPMC, Boric acid, Borax, Menthol and Camphor is safe and effective in the treatment of Ocular allergy.