First Clinical Insights into Melatonin Use for Dry Eye in Sjögren’s Syndrome

This pilot study evaluated the therapeutic effects of oral melatonin in patients diagnosed with primary Sjögren’s syndrome (pSS) and dry eye disease (DED). Twelve patients were treated with 5 mg of melatonin daily over an eight-week period. After treatment, significant improvements were recorded in Schirmer I test, tear break-up time (TBUT), and National Eye Institute (NEI) staining scores. Symptom severity decreased according to the Ocular Surface Disease Index (OSDI) and the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI). Additionally, a significant reduction in serum interleukin-6 (IL-6) levels was observed, while C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) remained unchanged. Visual inspection of individual scores demonstrated a consistent trend of clinical improvement. No adverse effects were reported during the study period. These preliminary findings suggest that melatonin supplementation could represent a safe, adjunctive therapeutic strategy for managing autoimmune dry eye in pSS patients. Further large-scale clinical trials are warranted to confirm these results and explore the underlying mechanisms.