A simple randomized comparative study to evaluate the efficacy of 0.7% w/v Olopatadine hydrochloride ophthalmic solution and the Fixed Dose Combination of 0.1% w/v Olopatadine hydrochloride and 0.4% w/v Ketorolac tromethamine ophthalmic solution for the
Abstract
Conjunctivitis is defined as the inflammation of the conjunctiva. Allergic conjunctivitis is an acute, intermittent or chronic inflammation of the conjunctiva due to air borne allergens. Allergic reactions occur when the immune system is hypersensitive to normally harmless environmental substances, called allergens. Allergic conjunctivitis is an increasingly prevalent allergic reaction and currently 40% of global population is suffering from allergic conjunctivitis. Being an immunopathological disease, Conjunctival mast cell degranulation plays a major role in ocular allergic disease and so treatment options should be concentrated on preventing degranulation or of antagonizing the effects of the primary mediator, histamine. Commonly used medications are: Topical OTC antihistamines (eg, ketotifen) , topical prescription antihistamines (eg, olopatadine, bepotastine, alcaftadine), NSAIDs (eg, ketorolac), or mast cell stabilizers (eg, nedocromil, cromolyn, azelastine) and can be used separately or in combination. In our study, the safety profile of Olopatadine 0.7% is comparable with fixed dose combination of Olopatadine 0.1% and ketorolac tromethamine 0.4% by assessing the reduction in the severity of four parameters (ocular itching, conjunctival hyperemia, chemosis and tearing) of allergic conjunctivitis over 14 days of daily treatment. Ours is a Prospective case observational study conducted from August 2018-January 2019. A total of 80 patients were screened from the ophthalmology outpatient department. All the subjects who fulfilled eligibility criteria were randomly assigned in equal proportions into two arms i.e, group-1(patients receiving 0.7% olopatidine Hcl eye drops) & group-2( patients receiving 0.1% olopatidine Hcl+ 0.4% ketorolac tromethamine eye drops.). It was observed that there was a significant difference in the percentage reduction of all the four parameters in the group 1 (i.e; patients treated with monotherapy) than the group 2 (i.e; patients treated with combination therapy). From this we concluded that monotherapy of 0.7% Olopatadine hydrochloride ophthalmic solution was found to be more effective in reducing the clinical signs and symptoms of allergic conjunctivitis than dual combination therapy of 0.1% Olopatadine hydrochloride + 0.4% Ketorolac tromethamine ophthalmic solution.
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