Effect of Hydroxychloroquine Treatment on Dry Eyes in subjects with Primary Sjögren's Syndrome: double blind randomized control study

Abstract

Introduction: Effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined yet. This study was aimed to compare the 12-weeks efficacy of HCQ medication with placebo in the management of dry eye in Primary Sjögren's Syndrome (pSS).

Methods: A double-blind, randomised control study was conducted in 39 subjects of 153 pSS subjects from May 2011 through August 2013. The diagnosis of Sjögren's syndrome was made on the basis of the classification criteria of the American-European Consensus Group. Subjects received 300 mg HCQ or placebo once daily for 12 weeks. Subjects were evaluated at baseline, 6 weeks and 12 weeks and re-visited at 16 weeks after drug discontinuance. Fluorescein staining score, Schirmer test score, tear film break-up time (TBUT), and ocular surface disease index (OSDI) were measured, and tears and blood were collected for ESR, IL-6, IL-17, B-cell activating factor (BAFF) and Th17 cell analysis. Color test and fundus were examined to monitor HCQ complications.

Results: Twenty-six subjects completed follow-ups. Fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication, but this was not insignificant between the groups. TBUT, Serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group.

Conclusions: HCQ at 300 mg daily has no apparent clinical benefit on dry eye and systemic inflammation in pSS.