Criteria for Sjogren's syndrome

I. Ocular Symptoms (at least one)

Dry eyes >3 months?
Foreign body sensation in the eyes?
Use of artificial tears >3x per day?

II. Oral Symptoms (at least one)

Dry mouth >3 months?
Recurrent or persistently swollen salivary glands?
Need liquids to swallow dry foods?

III. Ocular Signs (at least one)

Schirmer's test, (without anesthesia) ≤5 mm/5 minutes
Positive vital dye staining (van Bijsterveld ≥4)

IV. Histopathology 

Lip biopsy showing focal lymphocytic sialoadenitis
(focus score ≥1 per 4 mm2)

V. Oral Signs (at least one)

Unstimulated whole salivary flow (≤1.5 mL in 15 minutes)
Abnormal parotid sialography3
Abnormal salivary scintigraphy4

VI. Autoantibodies (at least one)

Anti-SSA (Ro) or Anti-SSB (La)

For a primary Sjögren’s diagnosis:
a. Any 4 of the 6 criteria, must include either item IV (Histopathology) or VI (Autoantibodies)
b. Any 3 of the 4 objective criteria (III, IV, V, VI)

For a secondary Sjögren’s diagnosis:
In patients with another well-defined major connective tissue disease, the presence of one symptom (I or II) plus 2 of the 3 objective criteria (III, IV and V) is indicative of secondary SS.

Exclusion Criteria

Past head and neck radiation treatment
Hepatitis C infection
Acquired immunodeficiency syndrome (AIDS)
Pre-existing lymphoma
Sarcoidosis
Graft versus host disease
Current use of anticholinergic drugs