PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: To evaluate the efficacy and safety of SHR8028, a water-free cyclosporine ophthalmic solution, 0.1%, compared with vehicle in Chinese participants with DED.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05841043.
UNASSIGNED: To evaluate the efficacy and safety of SHR8028, a water-free cyclosporine ophthalmic solution, 0.1%, compared with vehicle in Chinese participants with DED.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT05841043.
摘要：
■干眼病(DED)是一种普遍的眼病。环孢菌素是一种有效的免疫调节剂，广泛用于DED;然而，由于其高度疏水的性质，将环孢菌素递送至眼表具有挑战性。
■为了评估无水环孢素眼用溶液SHR8028的疗效和安全性，0.1%,与DED中国参与者的车辆相比。
■这是一个多中心，双盲,车辆控制,从2021年3月4日至2022年7月22日进行的3期随机临床试验。从中国的12家医院招募了患有中度至重度DED的成年参与者。对2022年4月2日的研究数据进行了初步分析。
■经过14天的人工泪液磨合期，参与者被随机分配(1:1)接受无水环孢素或载体(每只眼1滴眼液,每日2次).经过29天的治疗,两组参与者均可选择再接受12周的无水环孢素治疗,以进行长期安全性评估.
主要终点是使用国家眼科研究所量表的总角膜荧光素染色（tCFS）和在第29天的视觉模拟量表上的干燥评分从基线的变化。
■总共206名参与者(平均[SD]年龄，47.8[14.2]年；185名女性[90%]）登记，环孢菌素组和载体组各103。在第29天，与溶媒相比，环孢素组的tCFS有所改善（变化[Δ]=-1.8；95％CI，-2.7至-1.0；P<.001），环孢菌素组的tCFS评分从基线下降-4.8，媒介物组下降-3.0。两组干燥评分均较基线下降(-19.2vs-15.4;Δ=-3.8;95%CI,-9.2至1.6;P=.17)。在29天的治疗中，环孢菌素组15名参与者(14.6%)和媒介物组11名参与者(10.7%)报告了与治疗相关的不良事件.
■结果证明了无水环孢菌素的优越性，0.1%,在第29天，中国DED参与者在改善tCFS得分方面的眼部解决方案。然而,干燥评分(VAS)在第29天没有改善。
■ClinicalTrials.gov标识符：NCT05841043。
■为了评估无水环孢素眼用溶液SHR8028的疗效和安全性，0.1%,与DED中国参与者的车辆相比。
■这是一个多中心，双盲,车辆控制,从2021年3月4日至2022年7月22日进行的3期随机临床试验。从中国的12家医院招募了患有中度至重度DED的成年参与者。对2022年4月2日的研究数据进行了初步分析。
■经过14天的人工泪液磨合期，参与者被随机分配(1:1)接受无水环孢素或载体(每只眼1滴眼液,每日2次).经过29天的治疗,两组参与者均可选择再接受12周的无水环孢素治疗,以进行长期安全性评估.
主要终点是使用国家眼科研究所量表的总角膜荧光素染色（tCFS）和在第29天的视觉模拟量表上的干燥评分从基线的变化。
■总共206名参与者(平均[SD]年龄，47.8[14.2]年；185名女性[90%]）登记，环孢菌素组和载体组各103。在第29天，与溶媒相比，环孢素组的tCFS有所改善（变化[Δ]=-1.8；95％CI，-2.7至-1.0；P<.001），环孢菌素组的tCFS评分从基线下降-4.8，媒介物组下降-3.0。两组干燥评分均较基线下降(-19.2vs-15.4;Δ=-3.8;95%CI,-9.2至1.6;P=.17)。在29天的治疗中，环孢菌素组15名参与者(14.6%)和媒介物组11名参与者(10.7%)报告了与治疗相关的不良事件.
■结果证明了无水环孢菌素的优越性，0.1%,在第29天，中国DED参与者在改善tCFS得分方面的眼部解决方案。然而,干燥评分(VAS)在第29天没有改善。
■ClinicalTrials.gov标识符：NCT05841043。
