| I. Ocular symptoms: a positive response to at least one of the following questions: |
| 1. Have you had daily, persistent, troublesome dry eyes for more than three months? |
| 2. Do you have a recurrent sensation of sand or gravel in the eyes? |
| 3. Do you use tear substitutes more than three times a day? |
| II. Oral symptoms: a positive response to at least one of the following questions: |
| 1. Have you had a daily feeling of dry mouth for more than three months? |
| 2. Have you had recurrently or persistently swollen salivary glands as an adult? |
| 3. Do you frequently drink liquids to aid in swallowing dry food? |
| III. Ocular signs-that is, objective evidence of ocular involvement defined as a positive result for at least one of the following two tests: |
| 1. Schirmer’s I test, performed without anaesthesia (<5 mm in 5 minutes) |
| 2. Rose Bengal score or other ocular dye score (>4 according to van Bijsterveld’s scoring system) |
| IV. Histopathology: In minor salivary glands (obtained through normal-appearing mucosa) focal lymphocytic sialoadenitis, evaluated by an expert histopathologist, with a focus score >1, defined as a number of lymphocytic foci (which are adjacent to normal-appearing mucous acini and contain more than 50 lymphocytes) per 4 mm2 of glandular tissue |
| V. Salivary gland involvement: objective evidence of salivary gland involvement defined by a positive result for at least one of the following diagnostic tests: |
| 1. Unstimulated whole salivary flow (<1.5 mL in 15 minutes) |
| 2. Parotid sialography showing the presence of diffuse sialectasis (punctate, cavitary or destructive pattern), without evidence of obstruction in the major ducts |
| 3. Salivary scintigraphy showing delayed uptake, reduced concentration and/or delayed excretion of tracer |
| VI. Autoantibodies: presence in the serum of the following autoantibodies: |
| 1. Antibodies to Ro(SSA) or La(SSB) antigens, or both |
| Ro(SSA): Sjögren’s syndrome type A; La(SSB): Sjögren’s syndrome type B. |
