title: Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjögren's Syndrome: a Double-Blind Randomized Control Study.
abstract: The effect of hydroxychloroquine (HCQ) on dry eye has not been fully determined. This study aimed to compare the 12-week efficacy of HCQ medication with that of a placebo in the management of dry eye in primary Sjögren's syndrome (pSS). A double-blind, randomized control study was conducted in 39 pSS subjects from May 2011 through August 2013. pSS was diagnosed based on the classification criteria of the American-European Consensus Group. Subjects received 300 mg of HCQ or placebo once daily for 12 weeks and were evaluated at baseline, 6, and 12 weeks, with a re-visit at 16 weeks after drug discontinuance. The 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 testing was performed and the fundus was examined to monitor HCQ complications. Twenty-six subjects completed the follow-up. The fluorescein staining score and Schirmer test score did not differ significantly. The OSDI improved with medication in the HCQ group but was not significantly different between the groups. TBUT, serum IL-6, ESR, serum and tear BAFF, and the proportion of Th17 cells did not change in either group. HCQ at 300 mg daily for 12 weeks has no apparent clinical benefit for dry eye and systemic inflammation in pSS (ClinicalTrials.gov. NCT01601028).
authors.affiliation: Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea.; Laboraory of Ocular Regenerative Medicine and Immunology, Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea.
authors.forename: Chang Ho
authors.identifier: 0000-0003-2203-5709
authors.initials: CH
authors.lastname: Yoon
authors.affiliation: Laboraory of Ocular Regenerative Medicine and Immunology, Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea .
authors.forename: Hyun Ju
authors.identifier: 0000-0001-7022-4331
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea .
authors.forename: Eun Young
authors.identifier: 0000-0001-6975-8627
authors.initials: EY
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea .
authors.forename: Eun Bong
authors.identifier: 0000-0003-0703-1208
authors.initials: EB
authors.lastname: Lee
authors.affiliation: Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea .
authors.forename: Won-Woo
authors.identifier: 0000-0002-5347-9591
authors.initials: WW
authors.lastname: Lee
authors.affiliation: Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea.; Laboraory of Ocular Regenerative Medicine and Immunology, Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea.
authors.forename: Mee Kum
authors.identifier: 0000-0001-7850-6894
authors.initials: MK
authors.lastname: Kim
authors.affiliation: Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea.; Laboraory of Ocular Regenerative Medicine and Immunology, Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea.
authors.forename: Won Ryang
authors.identifier: 0000-0003-2590-5490
authors.initials: WR
authors.lastname: Wee
mesh_terms: D000368:Aged; D053264:B-Cell Activating Factor / Q000032:analysis / Q000097:blood; D001799:Blood Sedimentation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D015352:Dry Eye Syndromes / Q000150:complications / Q000188:drug therapy*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D019410:Interleukin-16 / Q000032:analysis / Q000097:blood; D020381:Interleukin-17 / Q000032:analysis / Q000097:blood; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D011446:Prospective Studies; D012859:Sjogren's Syndrome / Q000150:complications* / Q000175:diagnosis; D058504:Th17 Cells / Q000166:cytology / Q000276:immunology; D016896:Treatment Outcome
chemical_list: D053264:B-Cell Activating Factor; D019410:Interleukin-16; D020381:Interleukin-17; D006886:Hydroxychloroquine
keywords: Double-Blind Method; Dry Eye Syndromes; Hydroxychloroquine; Prospective Studies; Sjögren's Syndrome