Virginia Eye Consultants, Eyecare Partners, Norfolk, Virginia.
Medical Optometry America, Shrewsbury, Pennsylvania.
Optom Vis Sci. 2023 Feb 1;100(2):164-169. doi: 10.1097/OPX.0000000000001986. Epub 2022 Dec 31.
There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface-sparing nasal spray therapy, demonstrated significant improvement in both signs and symptoms of dry eye disease in subjects with mild, moderate, and severe symptoms as the clinical studies enrolled a more real-world patient population.
This study evaluated efficacy outcomes for VNS in patients with mild-moderate and severe dry eye disease.
An analysis of integrated data from two randomized clinical trials, ONSET-1 (NCT03636061) and ONSET-2 (NCT04036292) (vehicle control [VC], n = 294; VNS 0.03 mg, n = 308), was performed. Adults 22 years or older with dry eye disease, Ocular Surface Disease Index score of ≥23, corneal fluorescein staining score of ≥2 in ≥1 regions/≥4 all regions, and Schirmer Test Score (STS) of ≤10 mm (no restrictions on Eye Dryness Score [EDS]) were included in this study. Efficacy was evaluated using analysis of covariance among pre-specified subgroups of mild-moderate and severe baseline disease severity defined by STS (≤5 vs. >5) and EDS (<60 vs. ≥60). Consistency of effect was evaluated by interaction tests.
No treatment-subgroup interactions were observed for all end points ( P > .05). The odds of achieving a ≥10-mm improvement in STS for VNS versus VC for patients with baseline STS ≤5 and >5 were 3.4(95% confidence interval, 2.0 to 5.6) and 2.3(1.3 to 4.0) and for EDS of <60 and ≥60 were 3.4(1.9 to 6.1) and 2.5(1.5 to 4.0). Least-squares mean treatment/VC differences in change from baseline in EDS for patients with baseline STS ≤5 or >5 were -7.4(95% confidence interval, -12.5 to -2.4) and -2.8(-8.7 to 3.1); EDS of <60 and ≥60 were -2.9(-8.3 to 2.5) and -8.1(-13.6 to -2.6).
Compared with VC, VNS improved tear production and patient-reported symptoms in patients with dry eye disease, demonstrating consistency of effect regardless of initial presenting severity.
对于表现出不同严重程度的干眼症患者，临床需要一种能够广泛治疗的治疗方法。维替氯胺鼻喷雾剂（VNS）是一种独特的胆碱能激动剂眼表面保护的鼻腔喷雾疗法，在轻度、中度和重度症状的受试者中，均显著改善了干眼症的体征和症状，因为临床研究纳入了更接近实际患者人群。
本研究评估了 VNS 治疗轻中度和重度干眼症患者的疗效。
对两项随机临床试验 ONSET-1（NCT03636061）和 ONSET-2（NCT04036292）的整合数据进行了分析（载体对照[VC]，n=294；VNS 0.03mg，n=308）。纳入年龄 22 岁或以上的干眼症患者，眼表面疾病指数评分≥23，角膜荧光素染色评分≥2 在≥1 个区域/≥4 个所有区域，和 Schirmer 测试评分（STS）≤10mm（对眼干燥评分[EDS]无限制）。使用协方差分析评估了预先指定的轻度至中度和重度基线疾病严重程度亚组（STS≤5 与>5 和 EDS<60 与≥60）的疗效。通过交互检验评估了效果的一致性。
对于所有终点，均未观察到治疗-亚组的相互作用（P>.05）。对于基线 STS≤5 和>5 的患者，与 VC 相比，VNS 达到 STS 改善≥10mm 的可能性分别为 3.4（95%置信区间，2.0 至 5.6）和 2.3（1.3 至 4.0），对于 EDS<60 和≥60 的患者，可能性分别为 3.4（1.9 至 6.1）和 2.5（1.5 至 4.0）。对于基线 STS≤5 或>5 的患者，与 VC 相比，基线至 EDS 的最小二乘均值治疗/VC 差异分别为-7.4（95%置信区间，-12.5 至-2.4）和-2.8（-8.7 至 3.1）；对于 EDS<60 和≥60 的患者，差异分别为-2.9（-8.3 至 2.5）和-8.1（-13.6 至-2.6）。
与 VC 相比，VNS 改善了干眼症患者的泪液产生和患者报告的症状，显示出无论初始表现严重程度如何，效果均一致。
