To evaluate a commercially available dexamethasone intracanalicular insert to treat dry eye. Single-center, double-masked, randomized controlled trial. Patients with clinically significant aqueous-deficient dry eye [combined ocular surface staining score ≥3 (0-12), corneal fluorescein staining ≥2 (0-6), and Schirmer’s wetting <10 mm at 5 minutes in both eyes] with symptoms (dryness, eye discomfort, or visual fatigue, ≥30 [0-100]) despite treatment with at least one prescription drop and deemed candidate for topical steroid. Seventy-five adult patients were enrolled. A 1:1 randomization sequence was used to determine which eye of each patient would receive the treatment (dexamethasone 0.4 mg intracanalicular insert with 30-day elution time) or the sham (collagen plug). The fellow eye received the opposite treatment. Patients were masked to treatment assignment. Follow-up visits (at weeks 2, 4, and 6) were performed by a masked investigator. Dry eye parameters and patient symptoms were used for efficacy and intraocular pressure (IOP) was used for safety assessment. The severity of dry eye was comparable between the treatment arms (fellow eyes) at baseline. Eyes that received the dexamethasone insert had significantly less corneal staining at week 4 (mean difference [MD] −0.55, 95% confidence interval [CI] = −0.91, −0.19) and conjunctival staining at week 4 (MD −0.68, 95% CI = −1.05, −0.30) and week 6 (MD −0.34, 95% CI = −0.65, −0.02). Schirmer’s wetting was comparable between the two treatment arms. Although the patients reported less dryness in eyes that received the insert at week 4 (MD −5.5, 95% CI = −11.4, 0.4), there were no statistically significant differences in any patient-reported symptoms. At week 4, dexamethasone-treated eyes were more likely to experience an IOP increase (by 5-10 mm Hg) (9 eyes vs. 1 eye; relative risk [RR] = 9.00, 95% CI = 1.14, 71.0; due to sparse events, the CI was very wide). All cases of increased IOP were managed with short-term topical beta blockers and subsided. Dexamethasone intracanalicular insert may be considered a dropless dual treatment for clinically significant aqueous-deficient dry eye when topical steroid treatment is deemed appropriate.

中文翻译：

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地塞米松泪管内插入物治疗临床上显着的水液缺乏性干眼症：一项随机对照试验

评估市售的地塞米松泪管内插入物治疗干眼的效果。单中心、双盲、随机对照试验。具有临床显着的水缺乏性干眼症的患者[双眼表面染色评分≥3（0-12），角膜荧光素染色≥2（0-6），并且双眼5分钟时Schirmer湿润度<10mm]有以下症状（尽管使用至少一种处方滴剂进行治疗，但仍出现干涩、眼部不适或视疲劳，≥30 [0-100]），并且被认为是外用类固醇的候选者。招募了 75 名成年患者。使用 1:1 随机序列来确定每位患者的哪只眼睛将接受治疗（地塞米松 0.4 mg 泪小管内插入物，洗脱时间为 30 天）或假眼（胶原塞）。另一只眼睛接受相反的治疗。患者对治疗分配不知情。随访（第 2、4 和 6 周）由蒙面调查员进行。干眼参数和患者症状用于疗效评估，眼压（IOP）用于安全性评估。基线时，治疗组（同侧眼睛）的干眼严重程度相当。接受地塞米松插入物的眼睛在第 4 周时角膜染色显着减少（平均差 [MD] -0.55，95% 置信区间 [CI] = -0.91，-0.19），在第 4 周时结膜染色显着减少（MD -0.68，95%） CI = -1.05，-0.30）和第 6 周（MD -0.34，95% CI = -0.65，-0.02）。两个治疗组之间的 Schirmer 润湿程度相当。尽管患者报告在第 4 周接受植入物后眼睛干燥程度减轻（MD -5.5，95% CI = -11.4，0.4），但患者报告的任何症状均没有统计学上的显着差异。在第 4 周，地塞米松治疗的眼睛更有可能出现 IOP 升高（5-10 mm Hg）（9 只眼 vs. 1 只眼；相对风险 [RR] = 9.00，95% CI = 1.14，71.0；由于事件稀疏，CI 非常宽）。所有眼压升高的病例均通过短期外用β受体阻滞剂进行治疗并得到缓解。当认为局部类固醇治疗合适时，地塞米松泪小管内插入物可被认为是一种无滴双重治疗方法，用于治疗临床显着的水液缺乏性干眼症。