a Aciont Inc , Salt Lake City , UT , USA.
b KCT Data Inc , Alpharetta , GA , USA.
Curr Eye Res. 2019 Feb;44(2):185-193. doi: 10.1080/02713683.2018.1540707. Epub 2018 Nov 15.
Frequent steroid drops represent a challenge in patient compliance. This study evaluated the safety and efficacy of 5 minute topical dexamethasone sodium phosphate-Visulex (DSP-Visulex) treatment regimen (two applications on the first week then weekly after) compared to daily prednisolone acetate 1% (PA) for noninfectious anterior uveitis.
Forty-four patients were randomized to 8% DSP-Visulex with placebo eye drops (8% group, n = 14), 15% DSP-Visulex with placebo eye drops (15% group, n = 15), or Vehicle-Visulex with PA eye drops (PA group, n = 15). Patients received daily eye drops and Visulex treatments on days 1, 3, 8, and 15 with an optional treatment on day 22. Efficacy measures were change in anterior chamber cell (ACC) count from baseline and proportion of patients with zero ACC count at days 8, 15, and 29. Safety measures were adverse events (AEs), visual acuity, ocular symptoms, and intraocular pressure (IOP).
ACC resolution over time was similar among the three groups. The percentage of patients with clear ACC was 18%, 22%, and 15% on day 8; 27%, 56%, and 54% on day 15; and 90%, 88%, and 77% on day 29 for the 8%, 15%, and PA groups, respectively. The numbers of reported AEs were 10, 36, and 12 for the 8%, 15%, and PA groups, respectively. Ten patients among all groups experienced treatment-related AEs, which included headache, eye pain, corneal abrasion, conjunctival/corneal staining, conjunctivitis, visual acuity reduction, and keratitis all of which were resolved during the timeframe of patients' participation in the study. IOP elevation was noted in the PA group throughout the study, whereas IOP elevation in the DSP-Visulex groups was observed at day 3 but not thereafter.
The efficacy of the DSP-Visulex applications was comparable to the daily PA drops in the treatment of noninfectious anterior uveitis. Both 8% and 15% DSP-Visulex treatments were safe and well tolerated.
频繁使用类固醇滴眼剂会给患者的依从性带来挑战。本研究评估了 5 分钟局部磷酸二氢钠地塞米松-Visulex（DSP-Visulex）治疗方案（第 1 周使用 2 次，然后每周 1 次）与每日 1%醋酸泼尼松龙（PA）治疗非感染性前葡萄膜炎的安全性和疗效。
44 名患者被随机分为 8% DSP-Visulex 加安慰剂滴眼液（8%组，n=14）、15% DSP-Visulex 加安慰剂滴眼液（15%组，n=15）或 Vehicle-Visulex 加 PA 滴眼液（PA 组，n=15）。患者在第 1、3、8 和 15 天接受每日滴眼治疗和 Visulex 治疗，并在第 22 天进行可选治疗。疗效评估指标为前房细胞（ACC）计数从基线的变化和第 8、15 和 29 天 ACC 计数为零的患者比例。安全性评估指标为不良事件（AE）、视力、眼部症状和眼内压（IOP）。
三组间 ACC 随时间的缓解情况相似。第 8 天时，8%、15%和 PA 组的患者中 ACC 清晰的比例分别为 18%、22%和 15%；第 15 天分别为 27%、56%和 54%；第 29 天分别为 90%、88%和 77%。8%、15%和 PA 组分别报告了 10、36 和 12 例不良事件。所有组中有 10 例患者发生了与治疗相关的 AE，包括头痛、眼痛、角膜擦伤、结膜/角膜染色、结膜炎、视力下降和角膜炎，所有这些 AE 均在患者参与研究的时间段内得到解决。PA 组在整个研究过程中均出现 IOP 升高，而 DSP-Visulex 组在第 3 天出现 IOP 升高，但此后未再出现。
DSP-Visulex 滴眼剂的疗效与每日 PA 滴眼剂相当，用于治疗非感染性前葡萄膜炎。8%和 15%的 DSP-Visulex 治疗均安全且耐受良好。
