ORIGINAL RESEARCH article
Front. Med.
Sec. Ophthalmology
This article is part of the Research TopicAdvances in Ocular Autoimmune DiseasesView all 10 articles
Enhanced Efficacy of 0.05% Cyclosporine A Combined with Absorbable Punctal Plugs in Sjögren's Syndrome-Associated Dry Eye: A Paired-Eye Clinical Trial
Provisionally accepted
- Tianjin Eye Hospital, Tianjin, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
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). Conclusions: 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
Keywords: Sjögren's syndrome, dry eye, Cyclosporine A, Absorbable punctal plugs, Paired-eye study
Received: 28 Jul 2025; Accepted: 24 Nov 2025.
Copyright: © 2025 Dong, Cao, Li, Yang and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Luxia Chen, chen2006317@126.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.