JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2023.0709
Published online April 6, 2023

中文摘要

這篇文章是一項階段三的多中心、隨機、雙盲、安慰劑對照的臨床試驗，旨在評估一種無水的0.1%cyclosporine環孢素眼用溶液（CyclASol [Novaliq GmbH]）每日兩次用於治療中度至重度乾眼症的療效、安全性和耐受性。研究對象是從2020年12月5日至2021年10月8日在27個臨床中心招募的834名乾眼症患者，他們在使用人工淚液14天後被隨機分配到環孢素組或安慰劑組，並持續治療29天。研究的主要終點是第29天時與基線相比的total corneal fluorescein staining（tCFS）和dryness score（0-100 visual analog scale）的變化。結果顯示，環孢素組在tCFS和dryness score (dryness and blurred vision)方面均顯著優於安慰劑組（P < .001），並且具有快速起效和良好耐受性的特點。研究結論是，無水的0.1%環孢素眼用溶液每日兩次用於治療中度至重度乾眼症是有效和安全的。

English Abstract

This article is a phase 3, multicenter, randomized, double-masked, vehicle-controlled clinical trial that aims to evaluate the efficacy, safety, and tolerability of a water-free cyclosporine ophthalmic solution, 0.1% (CyclASol [Novaliq GmbH]), applied twice daily in dry eye disease (DED) compared with vehicle. The study participants were 834 patients with moderate to severe DED who were recruited from 27 clinical centers from December 5, 2020, to October 8, 2021. They were randomly assigned to cyclosporine or vehicle groups after using artificial tears for 14 days and continued treatment for 29 days. The primary outcomes were changes from baseline in total corneal fluorescein staining (tCFS, 0-15 National Eye Institute scale)) and in dryness score (0-100 visual analog scale) at day 29. The results showed that cyclosporine group had significantly better outcomes than vehicle group in tCFS and dryness score about dryness and blurred vision (P < .001), and had a rapid onset (2 weeks) of action and a good tolerability profile. The study concluded that water-free cyclosporine ophthalmic solution, 0.1%, applied twice daily was effective and safe for the treatment of moderate to severe DED.