Enhanced efficacy of 0.05% cyclosporine a combined with absorbable punctal plugs in Sjögren’s syndrome-associated dry eye: a paired-eye clinical trial

Introduction To compare the efficacy of combination therapy using 0.05% cyclosporine A (CsA) and absorbable punctal plugs with that of CsA monotherapy in patients with Sjögren’s syndrome-associated dry eye (SS-DE) using a paired-eye randomized controlled design. Methods This prospective, randomized, observer-masked, paired-eye clinical trial included 21 patients (42 eyes) with SS-DE. One eye of each patient received 0.05% CsA plus an absorbable lower punctal plug, whereas the contralateral eye received CsA monotherapy. Clinical assessments, including the Ocular Surface Disease Index (OSDI), visual analog scale (VAS), noninvasive tear breakup time (NIBUT), tear meniscus height (TMH), and corneal dendritic cell (DC) density (measured via in vivo confocal microscopy), were conducted at baseline and after 3 months. Intra-and intergroup comparisons were performed using paired t-tests. Pearson’s correlation and linear regression analyses were used to evaluate the association between ΔVAS and ΔOSDI. Results After 3 months, both groups showed significant improvements across all parameters ( p < 0.01). The combined treatment group demonstrated significantly greater improvements in NIBUT ( p < 0.01), TMH ( p < 0.05), DC density ( p < 0.01), and VAS scores ( p < 0.01) than the CsA monotherapy group. A significant positive correlation between ΔVAS and ΔOSDI was found in the combined treatment group (r = 0.528, p = 0.014), but not in the CsA monotherapy group (r = −0.172, p = 0.456). Conclusion Combination therapy with 0.05% CsA and absorbable punctal plugs yields superior improvements in both objective clinical signs and subjective symptoms compared to CsA monotherapy in SS-DE. This approach may enhance drug efficacy and patient comfort, offering an optimal therapeutic strategy for autoimmune-related dry eye. Clinical trial registration [ ClinicalTrials.gov ] Identifier: NCT07171710.