Abstract

A STUDY OF EFFICACY AND SAFETY OF LOTEPREDNOL VERSUS CYCLOSPORINE AS AN ADD ON THERAPY TO CARBOXYMETHYL CELLULOSE IN COMPARISON TO CARBOXYMETHYL CELLULOSE AS MONOTHERAPY IN DRY EYE DISEASE

Misra S.*, Kaushal J. and Khurana A. K.

ABSTRACT

Objective: To study efficacy and safety of loteprednol versus cyclosporine A as an add on therapy to carboxymethyl cellulose (CMC) versus carboxymethyl cellulose as monotherapy in dry eye disease. Material & Methods: A prospective, randomized, comparative, clinical study was conducted on 60 patients. The patients were randomly divided in three groups of 20 each to receive following three treatments: Group A (n=20) CMC 1% 6 times a day as monotherapy, Group B (n=20) CMC 1% 6 times a day and loteprednol 0.5% 4 times a day and Group C (n=20) CMC 1% 6 times a day and cyclosporine A 0.5% 4 times a day for a period 8 weeks. Efficacy assessment was done at the end of 2, 4, 6 and 8 weeks by Schirmer-I, Tear break up time (TBUT) test, Rose Bengal staining, Lissamine staining, Fluorescein staining and Marginal tear strip. Safety was assessed by monitoring of adverse drug reactions and ophthalmological examination. Results: Improvement of Schirmer`s test score in Group A, B and C was 5.85, 8.15 and 6.65 mm/5min respectively, while of TBUT score, it was 5.05, 7.7 and 6.2 sec respectively over a period of 8 weeks. Reduction of Rose Bengal staining score in Group A, B and C was 3.45, 4.8 and 3.75 respectively while of Lissamine staining score, it was 3.05, 3.90 and 3.4 respectively. Sticking of eyelashes, blurring and redness in the eyes were the most common adverse effects observed in all the groups. Conclusion: Loteprednol plus CMC was found to be more safe and efficacious than cyclosporine A plus CMC and CMC alone.

Keywords: Dry eye disease, CMC, Cyclosporine, Loteprednol.