Stanford University School of Medicine, Byers Eye Institute at Stanford, Palo Alto, California, USA.
Tufts University School of Medicine, Boston, Massachusetts, USA.
Am J Ophthalmol. 2020 Jul;215:56-65. doi: 10.1016/j.ajo.2020.03.018. Epub 2020 Mar 25.
To evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis.
Randomized, double-masked, multicenter, phase 3 clinical trial.
Subjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits.
Overall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity).
In this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.
评估聚维酮碘 0.6%（PVP-I）和地塞米松 0.1%（DEX）的局部滴眼混悬剂组合用于治疗细菌性结膜炎的感染和炎症成分的疗效和安全性。
随机、双盲、多中心、3 期临床试验。
所有年龄的受试者（<3 个月的受试者必须为足月）均被诊断为细菌性结膜炎，按 3:1:3 的比例随机分为 PVP-I/DEX、PVP-I 单药和安慰剂组。主要终点为研究眼的临床缓解，关键次要疗效终点为第 5 天的细菌清除。所有就诊时均记录不良事件（AE）。
共有 753 名受试者（意向治疗 [ITT] 人群；PVP-I/DEX [n=324]；PVP-I [n=108]；安慰剂 [n=321]）被随机分组；平均年龄（标准差）为 44.3（22.9）岁，大多数为女性（61.2%）和白人（78.1%）。在所有治疗组中，平均治疗依从性均>98%。疗效分析的改良 ITT 人群包括 526 名受试者。在第 5 天就诊时，研究眼的临床缓解率分别为 PVP-I/DEX 组 50.5%（111/220）和安慰剂组 42.8%（95/222）（P=0.127），细菌清除率分别为 43.3%（94/217）和 46.8%（102/218）（P=0.500）。安全性人群中分别有 32.8%（106/323）、39.8%（43/108）和 19.0%（61/321）的受试者发生治疗后出现不良事件，这些事件多为轻度（PVP-I/DEX、PVP-I 和安慰剂）。
在这项研究中，与安慰剂相比，PVP-I/DEX 在患有细菌性结膜炎的受试者中并未显示出在临床疗效方面的额外获益。
