[Prospective, monocentric, uncontrolled study of efficacy, tolerance and adherence of cyclosporin 0.1 % for severe dry eye syndrome].

Purpose: 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.

Material And Methods: A prospective, monocentric, uncontrolled study was conducted between January 2012 and March 2015 on 110 eyes of 55 patients 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.

Results: A total of 72 eyes of 37 patients were included. Etiologies of dry eye syndrome were dominated by Sjögren syndrome (32 %) and severe ocular surface conditions (48 %). The mean age was 57.7 years (±17.45) and mean follow-up was 458 days (±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.

Conclusion: 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.