Is There a Role for a Long Term Tapered Small Dose Steroidal Treatment for Keratoconjunctivitis Sicca?

Abstract

Purpose: : To evaluate the safety and the ability of a long term treatment of small tapered doses of steroid (loteprednol etabonate) in controlling and improving signs and symptoms of keratoconjunctivitis sicca (KCS).

Methods: : 36 patients with KCS have been enrolled for this study. Diagnosis of KCS and treatment outcomes were assessed by means of OSDI Questionnaire, Schirmer I test, tear break-up time (BUT), lissamine green conjunctival staining (NEI scoring system), and fluorescein corneal staining. The enrolled patients were divided into 2 groups: Group 1 composed of 12 subjects was treated with an initial treatment with loteprednol etabonate 0.5% suspension b.i.d. for 10 days, associated with continuous use t.i.d. of tear substitutes. Group 2 was treated b.i.d. with loteprednol etabonate 0.5% for 7 days tapered at 1x die for 15 days, then every other day for 3 weeks, then 2 days a week together with the usual dosage of tear substitutes. Best corrected visual acuity and intraocular pressure were all recorded for each eye. The mentioned evaluations have been repeated at each control after 3,6,12 months since the beginning of steroid therapy.

Results: : All the groups showed a significant reduction of both signs and symptoms if compared to baseline (p<0.001), nevertheless Group 2 treated by means of tapered long term doses of loteprednol etabonate suspension performed significantly better (p<0.001) than the ones using tear substitutes therapy after a starting single shot of steroids. None of the treated eyes showed significant increase in intraocular pressure or worsening of best corrected visual acuity.

Conclusions: : Long term treatment with tapered mini doses of loteprednol etabonate 0.5% suspension seems to provide excellent results on signs and symptoms of patients with KCS, albeit it seems to be quite effective and safe at the used dosages, its real safety has to be confirmed in larger studies.

Keywords: cornea: tears/tear film/dry eye