The Eye Care Institute, Louisville, KY, USA.
Advancing Vision Research LLC, Nashville, TN, USA.
Ocul Surf. 2020 Apr;18(2):249-257. doi: 10.1016/j.jtos.2019.09.006. Epub 2019 Sep 19.
To evaluate the safety and effectiveness of the intranasal tear neurostimulator (ITN) in improving dry eye symptoms assessed in a controlled adverse environment (CAE®).
Study 1: Multicenter, subject-masked, randomized-sequence, crossover design. Single intranasal (active) and extranasal (control) ITN administration during CAE exposure. Study 2: Single-arm, open-label design. Intranasal ITN administration ≥2 times/day for 45 days, CAE assessment at days 0 and 45. In both studies, upon CAE entry, and every 5 min thereafter, subjects assessed eye dryness score (visual analog scale, 0-100 mm; EDS-VAS), and ocular discomfort score (ODS; Ora Calibra™, 0-4), for ≈2 h. Study 1: when ODS was ≥3 at 2 consecutive timepoints, subjects applied ITN intranasally or extranasally for ≈3 min, and again when achieving the same ODS criteria in randomized sequence. Study 2: days 0 and 45, ITN was applied for ≈3 min employing the same ODS criteria as Study 1.
Study 1: Significantly greater pre- to post-application reductions in mean [SEM] EDS (-16.5 [1.7] vs -3.1 [1.7], P < 0.0001) and ODS (-0.93 [0.08] vs -0.34 [0.08], P < 0.0001; n = 143) with intranasal vs extranasal stimulation. Study 2: On day 0 (n = 52) and day 45 (n = 48), significant pre- to post-application reductions in mean [SEM] EDS (-15.9 [2.7] and -15.2 [2.4]; P < 0.0001), and ODS (-1.3 [0.2] and -1.3 [0.1]; P < 0.0001). Few device-related adverse events were reported, none serious.
Acute symptom relief is significant with the ITN and remains undiminished after daily use.
评估经鼻泪液神经刺激器（ITN）在改善受控不良环境（CAE®）中评估的干眼症症状的安全性和有效性。
研究 1：多中心、受试者设盲、随机序列、交叉设计。在 CAE 暴露期间，单次经鼻（活性）和经鼻外（对照）ITN 给药。研究 2：单臂、开放标签设计。每天至少两次经鼻 ITN 给药 45 天，在第 0 天和第 45 天进行 CAE 评估。在这两项研究中，在进入 CAE 后，每 5 分钟评估一次眼睛干燥评分（视觉模拟量表，0-100mm；EDS-VAS）和眼部不适评分（Ora Calibra™，0-4），持续约 2 小时。研究 1：当连续两个时间点的 ODS 均≥3 时，受试者以随机顺序经鼻或经鼻外 ITN 给药约 3 分钟，当达到相同的 ODS 标准时再次给药。研究 2：第 0 天和第 45 天，根据研究 1 中的相同 ODS 标准，经鼻 ITN 给药约 3 分钟。
研究 1：与经鼻外刺激相比，应用 ITN 后 EDS（-16.5 [1.7] 与-3.1 [1.7]，P < 0.0001）和 ODS（-0.93 [0.08] 与-0.34 [0.08]，P < 0.0001；n = 143）的平均（SEM）降低幅度更大。研究 2：在第 0 天（n = 52）和第 45 天（n = 48），EDS（-15.9 [2.7] 和-15.2 [2.4]；P < 0.0001）和 ODS（-1.3 [0.2] 和-1.3 [0.1]；P < 0.0001）的平均（SEM）降低幅度在应用前和应用后都有显著差异。报告了少数与设备相关的不良事件，均不严重。
ITN 可显著缓解急性症状，且每日使用后缓解效果仍不减弱。
