Purpose: Sjögren’s is a systemic autoimmune disease that can impair lacrimal gland function, resulting in dry eye and ocular surface damage. While studies have shown a correlation between Sjögren’s dry eye and corneal neurosensory abnormalities, the prevalence of corneal nerve impairment in patients with Sjögren’s dry eye is not well established. This study evaluated the proportion of patients with Sjögren’s dry eye who have impaired corneal sensitivity, with an aim to advance understanding of ocular surface neurobiology and support improved diagnostic and management strategies.

Methods: This multicenter, observational study enrolled adults with Sjögren’s dry eye at 13 U.S. sites. Patients completed the study in a single visit provided all qualification criteria were met. Eligibility required confirmed Sjögren’s diagnosis ≥3 months, dry eye diagnosis ≥3 months, and corneal fluorescein staining ≥1 on the NEI scale. The primary endpoint was the proportion of patients who demonstrated impaired corneal sensitivity (≤ 5 cm as determined by Cochet-Bonnet esthesiometer). Secondary and exploratory endpoints included mean corneal sensitivity and corneal epithelial staining (assessed using the NEI scale by an independent central reading center). The primary endpoint was estimated with 95% confidence intervals using the Wilson method. Summary statistics for continuous and categorical variables were used to assess secondary and exploratory endpoints.

Results: Of the 103 patients included in the Full Analysis Set, the mean (SD) age was 61.6 (13.1) years and 94.2% (n=97) were female. The mean (SD) time since first diagnosis of Sjögren’s dry eye was 101.4 (105.2) months. In this cohort, 70.9% (n=73; 95% CI: 61.5; 78.8) of patients demonstrated impaired corneal sensitivity in the study eye, with a mean (SD) corneal sensitivity in the study eye of 4.1 (1.6) cm (95% CI: 3.8; 4.4). The mean (SD) total score for corneal epithelial staining in the study eye was 2.3 (2.8) (95% CI: 1.7; 2.9).

Conclusions: This is one of the largest studies to date describing the prevalence of neurosensory abnormalities in patients with Sjögren's dry eye. These results demonstrate that corneal sensitivity testing may be an important diagnostic to perform in this subset of patients to better understand the impact that this autoimmune condition has on the physiology of the ocular surface.