Oral Hydroxychloroquine is safe and effective in treating primary Sjögren’s syndrome-related dry eye disease

Patients with primary Sjögren’s syndrome (pSS) often experience dry eye disease. Hydroxychloroquine (HCQ) has become a significant treatment option for pSS due to its immunomodulatory effects and minimal adverse effects. A recent study published in Alternative Therapies in Health and Medicine demonstrated the effectiveness and safety of HCQ in pSS patients with moderate to severe dry eye disease. 

Fang and colleagues  conducted the study on 72 patients diagnosed with pSS at First Affiliated Hospital of the Military Medical University of the Army, China, between October 2020 and 2022. The study subjects were randomly divided into two groups, the oral HCQ group and the control group, and were followed up for 12 months. All individuals were administered eye drops containing 0.05% cyclosporine. After 12 months, the HCQ group showed significant improvements in EULAR Sjögren’s syndrome patient reported index (ESSPRI), serum IgA, and Schirmer test I results compared to the control group (P <0.05). Both the groups showed notable improvements in Best Corrected Visual Acuity (BCVA), Ocular Surface Disease Index questionnaire (OSDI), Standard Patient Evaluation of Eye Dryness (SPEED) scores, and dry eye-associated examinations compared to baseline (P < .05). Serum IgG and IgM levels decreased in the HCQ group after 12 months of treatment. No adverse reactions such as hydroxychloroquine retinopathy and diarrhea were reported in patients with oral HCQ administration, according to the diagnostic criteria for hydroxychloroquine retinopathy. 

A study by Yavuz et al. comprising 32 patients with primary Sjogren’s disease reported that HCQ may alleviate symptoms and signs of dry eye in pSS and decrease tear fluid BAFF levels. The study evaluated the patients’ subjective symptom scoring, fluorescein and lissamine green staining, Schirmer’s test, tear break-up time (BUT), and tear fluid B-cell activating factor (BAFF) assessments at baseline and post-cessation of treatment. The results showed a significant worsening of tear break-up time (TBUT), lissamine green staining of the ocular surface, and corneal fluorescein staining scores between on and off HCQ treatment. There was also  significant change in gritty sensation and burning sensation at week 12 compared to baseline evaluation.  

HCQ may represent a safe and promising avenue for the management of dry eye disease associated with pSS. However, to establish its full effectiveness as a standalone treatment, there is a need for larger and more extended studies that incorporate objective measures for a comprehensive assessment. 


  1. Fang W, Qingqing Z, Qihui L, Bing Z, Xinyue H, Jie X. Safety and Efficacy of Oral Hydroxychloroquine in the Treatment of Ophthalmic Disease Associated with Sjögren’s Syndrome. Altern Ther Health Med. 2023 Sep 8;AT9009.  
  1. Yavuz S, Asfuroğlu E, Bicakcigil M, Toker E. Hydroxychloroquine improves dry eye symptoms of patients with primary Sjogren’s syndrome. Rheumatol Int. 2011 Aug;31(8):1045–9.