Anti-SSA and/or anti-SSB antibodies or (anti-nuclear antibodies at a level ≥ 1/320 and rheumatoid factor positive)

Presence of lymphocytic infiltrate on accessory salivary gland biopsy with focus score ≥ 1

Ocular staining score after examination with Lissamine green and fluorescein ≥ 3 (Ocular Staining Score)