Evaluation of the Efficacy and Safety of Topical 0.05% Cyclosporine Eye Drops (II) in the Treatment of Dry Eye Associated with Primary Sjögren’s Syndrome

ABSTRACT

Purpose

To evaluate the efficacy and safety of 0.05% cyclosporine eye drops (II) for the treatment of primary Sjögren’s syndrome-associated dry eye (PSSDE).

Methods

Sixty patients with PSSDE were randomly divided into three groups, received treatment with 0.05% cyclosporine (C group), artificial tears (S group) or their combination (CS group). The evaluation indicators were evaluated at baseline and at weeks 2, 4 and 12.

Results

The symptoms of C and CS groups were reduced significantly. The signs [schirmer I test (F = 4.838, p = .011), ocular staining score (F = 7.961, p = .001) and tear break-up time (F = 9.283, p < .001)] were significantly different between S and C groups as well as S and CS groups. The tear meniscus height (F = 3.197, p = .048) was significantly different between S and CS groups. No serious adverse events occurred.

Conclusion

0.05% cyclosporine is an effective and safe treatment for patients with PSSDE.

KEYWORDS:

• Cyclosporine
• dry eye disease
• keratoconjunctivitis sicca
• ocular staining score
• primary Sjögren’s syndrome

Acknowledgments

The authors would like to express their gratitude to the ophthalmological nurses of The Second Hospital of Dalian Medical University for their help and EditSprings (https://www.editsprings.cn/) for the expert linguistic services provided.

Disclosure statement

No potential conflict of interest was reported by the authors.

Author contributions

Conceptualization & Methodology, Mingjun Gao, Lin Zhao; Data Collection, Ran Liang; Software & Data Analysis, Qing Zhu; Writing-Review & Editing, Mingjun Gao; Conceptualization, Methodology and Support Contributions, Qi Zhao, Xiaodan Kong.

Additional information

Funding

The authors reported there is no funding associated with the work featured in this article.