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Randomized Controlled Trial
. 2024 Sep 9;24(1):401.
doi: 10.1186/s12886-024-03620-5.

Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation

Su Young Moon #  1 , Ho Seok Chung #  1   2 , Jae Hyuck Lee  1 , Hun Lee  1 , Hungwon Tchah  1 , Jae Yong Kim  3   4
Affiliations
Randomized Controlled Trial

Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation

Su Young Moon et al. BMC Ophthalmol. .

Abstract

Background: To compare and evaluate objective and subjective clinical parameters between 0.05% cyclosporine nanoemulsion (CsN) and 0.15% hyaluronic acid (HA) administration in patients with mild-to-moderate dry eyes.

Methods: In this prospective, randomized, double-masked, single-center, and placebo-controlled parallel study, patients with mild-to-moderate dry eyes were randomly allocated to be treated with 0.05% CsN or 0.15% HA twice daily. Patients were followed-up at 4, 8, and 12 weeks. Objective and subjective parameters were evaluated during each visit.

Results: A total of 35 patients were enrolled in this study. Compared with baseline, tear film break-up time and fluorescein staining scores at 4, 8, and 12 weeks significantly improved in the CsN group. However, the Schirmer I test showed no statistically significant change until week 12. Using the Symptom Assessment in Dry Eye (SANDE) score, both groups gradually showed significant improvement compared with baseline values. However, the Dry Eye-Related Quality-of-life Score Questionnaire (DEQS) showed no statistically significant change during the treatment period.

Conclusions: Both 0.05% CsN and 0.15% HA administration twice a day effectively improved the objective signs and subjective symptoms of patients with mild-to-moderate dry eyes. However, patients treated with 0.05% CsN experienced greater and faster improvement.

Keywords: Cyclosporine; Dry Eye-Related Quality of life score (DEQS); Dry eye; Symptom Assessment in Dry Eye (SANDE).

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Comparison between time points within groups and between the Hyaluronic acid group (dark gray) and the Cyclosporine A group (light gray) at 12 weeks. (A) tear break-up time (TBUT), (B) staining score by National Eye Institute (NEI) scale, and (C) Schirmer Test I without anesthesia. HA = Hyaluronic acid 0.15%; CsN = Cyclosporine Nanoemulsion 0.05%; *p < 0.05, **p < 0.001
Fig. 2
Fig. 2
Scatterplots showing the correlation between Symptom Assessment in Dry Eye (SANDE), Dry Eye-related Quality of life Score questionnaire (DEQS), and Ocular Discomfort Analog Scale (ODAS). (A) Pearson’s correlation coefficient analysis revealed a significant correlation between SANDE and DEQS scores (R = 0.672; p < 0.001) (B) Correlation between SANDE and ODAS1-7 scores (R = 0.796; p < 0.001) (C) Correlation between DEQS and ODAS1-7 scores (R = 0.756; p < 0.001)
See this image and copyright information in PMC

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