Changes in Signs and Symptoms of Dry Eye Disease after using 0.1% or 0.05% Emulsions of Cyclosporine A Eye Drops

Abstract

Purpose : Dry eye disease (DED) is often accompanied by a T-cell mediated inflammatory response affecting the ocular surface and is in moderate and severe cases treated with cyclosporine A (CsA). Various formulations of topical CsA drops are used around the globe but evidence of a possible difference with regards to efficacy is lacking. This study compared post-treatment signs and symptoms in DED patients who used 0.1% CsA cationic emulsion (Ikervis, Santen) or 0.05% CsA emulsion of castor oil-in-water (Restasis, Allergan).

Methods : This retrospective study consecutively analyzed 200 patients with DED of different etiologies treated with Ikervis (n=100) or Restasis (n=100) over six months at the Norwegian Dry Eye Clinic from 2012-2017. Patients underwent a comprehensive work-up including ocular surface staining (OSS; Oxford grading scheme), fluorescein break-up time (FBUT), Ocular Surface Disease Index (OSDI) questionnaire, Schirmer’s test, and meibomian expressibility (ME) and quality (MQ). Increased ME and MQ may indicate meibomian gland dysfunction. All patients received preservative free tear substitutes in addition to CsA. Ocular surface staining, TFBUT, ME, and MQ-values were evaluated with Wilcoxon’s signed rank test (not normally distributed), OSDI-scores with a paired sample t-test and age with independent sample t-test (normally distributed), and gender with a chi-square test. Results are shown as means and standard deviations.

Results : Following six months of treatment with Ikervis or Restasis, both OSS and FBUT improved significantly, OSDI values improved only for Restasis, and MQ only for Ikervis. Schirmer’s test and ME did not improve in either group. See Table 1 for detailed results and Table 2 for patient demographics.

Conclusions : Ikervis did not demonstrate significant subjective improvement in contrast to Restasis. Only Ikervis showed an improvement in MQ score, suggesting a positive effect on the meibomian glands. This indicates a difference in efficacy between the drugs that should be further explored in a randomized controlled trial.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Table 1 Results comparing Ikervis and Restasis over six months. *A decrease/†an increase is considered an improvement.

 

Table 2 Patient demographics