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

## TL;DR

A clinical trial found that combining cyclosporine A with punctal plugs improves dry eye symptoms more effectively than cyclosporine alone in patients with Sjögren’s syndrome.

## Contribution

Demonstrated that combining cyclosporine A with absorbable punctal plugs provides better outcomes than monotherapy in dry eye associated with Sjögren’s syndrome.

## Key findings

- Combined treatment improved tear breakup time, tear meniscus height, and corneal cell density more than cyclosporine alone.
- Patients reported greater symptom relief with the combination therapy compared to cyclosporine monotherapy.
- A significant correlation between symptom improvement and clinical outcomes was observed only in the combination group.

## Abstract

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.

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.

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).

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.

[ClinicalTrials.gov] Identifier: NCT07171710.