The ocular surface · 2026
Lifitegrast ophthalmic solution 5.0% (KH732) for dry eye disease: A randomized, multicenter, double-masked, vehicle-controlled phase 3 trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование III фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lu Yang, Jin Xiuming, Li Xiaofeng, Jie Ying, Tao Liming, Ren Shengwei, Zhao Shaozhen, Li Ying, Xu Guoxing, Zhuang Wenjuan, Li Ying, Chen Wei, Cai Shanjun, Gu Hao, Zhang Hong, Li Lan, You Zhipeng, Li Jianqiao, Zhao Jiangyue, Chen Qi, Huang Ting, Wu Pengcheng, Wang Ting, Yao Yong, Wang Hua, Li Zhuo, Shu Xiangwen, Wang Ruifeng, Zhang Mingchang, Wen Feng, Fu Yao, Pei Cheng, Zhang Wei, Guan Huaijin, Zhao Hui, Yang Jizhong, Song Lin, He Min, Lv Xingxiang, Wu Fusheng, Gong Lan, Sun Xinghuai
Аннотация
BACKGROUND: Dry eye disease (DED) commonly impairs quality of life. This phase 3, randomized, double-masked, multicenter, vehicle-controlled trial evaluated the efficacy of 5.0% lifitegrast ophthalmic solution (KH732) in improving signs and symptoms of DED.
METHODS: Adults with moderate-to-severe DED and corneal staining score ≥2.0 in any corneal region were randomized 1:1 to lifitegrast (KH732) or vehicle twice daily for 84 days after a 3-7-day vehicle washout. The primary endpoint was change from baseline in inferior corneal staining score (ICSS) at Day 84. Secondary endpoints included changes in total corneal staining score, Eye Dryness Score (EDS), Ocular Surface Disease Index (OSDI), 7-item visual analogue scale, and Ocular Discomfort Score.
RESULTS: At Day 84, lifitegrast (n = 309) significantly reduced ICSS versus vehicle (n = 306) (P = 0.027). In a post hoc analysis, the effect was more pronounced in participants with the highest baseline staining in the inferior region (P = 0.046). Lifitegrast also significantly improved EDS (adjusted P = 0.006), ocular discomfort (adjusted P = 0.010), photophobia (adjusted P = 0.004), and OSDI (adjusted P = 0.014) versus vehicle. Post hoc analyses showed significant between-group differences in EDS, photophobia, and OSDI as early as Day 14. No serious ocular adverse events were reported.
CONCLUSIONS: Lifitegrast (KH732) improved both signs and symptoms of DED and was generally well tolerated, with potentially greater benefit in patients with prominent inferior corneal staining.
METHODS: Adults with moderate-to-severe DED and corneal staining score ≥2.0 in any corneal region were randomized 1:1 to lifitegrast (KH732) or vehicle twice daily for 84 days after a 3-7-day vehicle washout. The primary endpoint was change from baseline in inferior corneal staining score (ICSS) at Day 84. Secondary endpoints included changes in total corneal staining score, Eye Dryness Score (EDS), Ocular Surface Disease Index (OSDI), 7-item visual analogue scale, and Ocular Discomfort Score.
RESULTS: At Day 84, lifitegrast (n = 309) significantly reduced ICSS versus vehicle (n = 306) (P = 0.027). In a post hoc analysis, the effect was more pronounced in participants with the highest baseline staining in the inferior region (P = 0.046). Lifitegrast also significantly improved EDS (adjusted P = 0.006), ocular discomfort (adjusted P = 0.010), photophobia (adjusted P = 0.004), and OSDI (adjusted P = 0.014) versus vehicle. Post hoc analyses showed significant between-group differences in EDS, photophobia, and OSDI as early as Day 14. No serious ocular adverse events were reported.
CONCLUSIONS: Lifitegrast (KH732) improved both signs and symptoms of DED and was generally well tolerated, with potentially greater benefit in patients with prominent inferior corneal staining.