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Comment
. 2024 Apr 1;142(4):337-343.
doi: 10.1001/jamaophthalmol.2024.0101.

Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial

Rongmei Peng  1   2 , Ying Jie  3 , Qin Long  4 , Lan Gong  5 , Lei Zhu  6 , Xingwu Zhong  7 , Shaozhen Zhao  8 , Xiaoming Yan  9 , Hao Gu  10 , Huping Wu  11 , Gang Li  12 , Kaiyun Zhang  13 , Sonja Krösser  14 , Ruxia Xu  13 , Jing Hong  1   2
Affiliations
Comment

Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease: A Randomized Clinical Trial

Rongmei Peng et al. JAMA Ophthalmol. .

Abstract

Importance: Dry eye disease (DED) is a prevalent eye disorder. Cyclosporine is an effective immunomodulator that is widely used in DED; however, due to its highly hydrophobic nature, delivery of cyclosporine to the ocular surface is challenging.

Objective: To evaluate the efficacy and safety of SHR8028, a water-free cyclosporine ophthalmic solution, 0.1%, compared with vehicle in Chinese participants with DED.

Design, setting, and participants: This was a multicenter, double-blind, vehicle-controlled, phase 3 randomized clinical trial conducted from March 4, 2021, to July 22, 2022. Adult participants with moderate to severe DED were recruited from 12 hospitals in China. Study data were analyzed April 2, 2022, for the primary analysis.

Interventions: Following a 14-day run-in period with an artificial tear, participants were randomly assigned (1:1) to receive water-free cyclosporine or vehicle (1 eye drop in each eye twice daily). After a 29-day treatment, participants of both groups were given the option to receive water-free cyclosporine for an additional 12 weeks for longer-term safety assessment.

Main outcomes and measures: The primary end points were changes from baseline in total corneal fluorescein staining (tCFS) using the National Eye Institute scale and in dryness score on a visual analog scale at day 29.

Results: A total of 206 participants (mean [SD] age, 47.8 [14.2] years; 185 female [90%]) were enrolled, with 103 each in the cyclosporine group and the vehicle group. At day 29, the cyclosporine group experienced improved tCFS compared with vehicle (change [Δ] = -1.8; 95% CI, -2.7 to -1.0; P < .001), with a tCFS score decrease from baseline of -4.8 in the cyclosporine group and -3.0 in the vehicle group. Dryness score decreased from baseline in both groups (-19.2 vs -15.4; Δ = -3.8; 95% CI, -9.2 to 1.6; P = .17). During the 29-day treatment, treatment-related adverse events were reported in 15 participants (14.6%) in the cyclosporine group and 11 participants (10.7%) in the vehicle group.

Conclusions and relevance: Results demonstrated superiority of a water-free cyclosporine, 0.1%, eye solution over vehicle in improving tCFS score at day 29 in Chinese participants with DED. However, dryness score (VAS) was not improved at day 29.

Trial registration: ClinicalTrials.gov Identifier: NCT05841043.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms Zhang reported being an employee of Jiangsu Hengrui Pharmaceuticals during the conduct of the study. Dr Krösser reported being an employee of Novaliq GmbH during the conduct of the study. Ms Xu reported being an employee of Jiangsu Hengrui Pharmaceuticals during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Participant Disposition Over the Study Treatment and Longer-Term Follow-Up
Figure 2.
Figure 2.. Change From Baseline in Total Corneal Fluorescein Staining (CFS) National Eye Institute (NEI) Scale and Dryness Score (Visual Analog Scale [VAS]) Over the 29-Day Treatment Period Full-Analysis Set
Data are least squares mean. Error bars show SE.
See this image and copyright information in PMC

Comment on

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