Étude prospective, monocentrique, non contrôlée de l’efficacité, de la tolérance et de l’adhésion au traitement par ciclosporine 0,1 % au cours des sécheresses oculaires sévères

Abstract

To evaluate the efficacy, tolerability and treatment adherence of Ikervis® (Santen, SAS) (ciclosporine 0.1%) for first line therapy or following treatment with Restasis® (Allergan, Inc.) (ciclosporine 0.05%) for severe dry eye syndrome. A prospective, monocentric, uncontrolled study was conducted between January 2012and March 2015on 110eyes of 55patients with severe dry eye on first line therapy or previously treated with Restasis® who required the introduction of Ikervis®. Patients' quality of life was assessed before and after treatment was started using a standardized questionnaire (Ocular Surface Disease Index© [OSDI]), clinical efficacy was quantified at the slit lamp, by measurement of the Break Up time Test (BUT) and the Oxford classification. Tolerability and adherence to treatment were measured using a simple questionnaire. A total of 72eyes of 37patients were included. Etiologies of dry eye syndrome were dominated by Sjögren syndrome (32%) and severe ocular surface conditions (48%). The mean age was 57.7years (±17.45) and mean follow-up was 458days (±292). The mean BUT increased by 2.043seconds [1.522-2.563] (P<0.0001). Corneal/conjunctival involvement evaluated by the Oxford classification was also improved with a difference in level of 1.68 [1.290-2.071] (P<0.0001). Ocular Surface Disease Index© (OSDI) decreased by 21.7 [16.372-27.024] (P<0.0001). Treatment tolerability was moderate, with more than 50% of patients experiencing pain on instillation. Overall satisfaction with treatment was good, with more than 60% of patients feeling better after initiation of treatment. Ikervis® is an effective treatment of severe dry eye. Its indications tend to evolve towards less severe dry eye. However, the tolerability profile remains poor, and an improvement in this would be desirable.