Fogagnolo Paolo, Quisisana Chiara, Caretti Anna, Marchina Daniele, Dei Cas Michele, Melardi Ettore, Rossetti Luca
Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.
Department of Health Sciences, Laboratory of Biochemistry, University of Milan, Milan, Italy.
Clin Ophthalmol. 2020 Jun 18;14:1651-1663. doi: 10.2147/OPTH.S258081. eCollection 2020.
To compare the efficacy of the new lubricating product VisuEvo (VSE) vs Cationorm (CTN) in patients with dry eye disease (DED).
Seventy-two patients with evaporative (n=54) and non-evaporative DED (n=18) were included in a multicenter, double-blind, 12-week cross-over study to receive VSE (6 weeks) and CTN (6 weeks) in randomized sequence. After baseline, two visits were performed during each period (intermediate and final visit, respectively at 2 and 6 weeks from the beginning of each period). Primary (tear break-up time, TBUT) and secondary endpoints (Schirmer I, Ferning, blink rate, osmometry, cytokine and lipid expression, ocular surface staining, patient satisfaction, and OSDI score) were compared.
Sixty-three patients were evaluated for efficacy and 68 patients for safety. The intergroup differences for mean TBUT values were not significant at any study visit (baseline 3.2 ±1.5 sec; intermediate visits 4.5 ± 1.9 and 4.5 ± 1.8 sec in VSE and CTN groups, respectively, p = 0.10; final visits 5.4 ± 2.4 and 6.0 ± 3.1, respectively, p=0.63). Also, the assessment of secondary endpoints showed no significant difference between the two groups. The two study treatments were equally effective in evaporative and non-evaporative DED. The safety profile was excellent for both ocular treatments; transient blurred vision was observed in 11 patients only during CTN, 10 patients only during VSE, and 16 during both treatments.
VSE was non-inferior to CTN in restoring tear film composition, increasing its stability and reducing ocular surface damage in evaporative and non-evaporative DED patients.
NCT03833882.
比较新型润滑产品VisuEvo（VSE）与Cationorm（CTN）对干眼症（DED）患者的疗效。
72例蒸发型（n = 54）和非蒸发型DED患者（n = 18）纳入一项多中心、双盲、12周交叉研究，随机顺序接受VSE（6周）和CTN（6周）治疗。基线后，在每个治疗期进行两次访视（中期和末期访视，分别在每个治疗期开始后的2周和6周）。比较主要终点（泪膜破裂时间，TBUT）和次要终点（Schirmer I试验、蕨样变、眨眼频率、渗透压测定、细胞因子和脂质表达、眼表染色、患者满意度和OSDI评分）。
63例患者接受疗效评估，68例患者接受安全性评估。在任何研究访视中，两组间平均TBUT值的差异均无统计学意义（基线时为3.2±1.5秒；VSE组和CTN组中期访视分别为4.5±1.9秒和4.5±1.8秒，p = 0.10；末期访视分别为5.4±2.4秒和6.0±3.1秒，p = 0.63）。此外，次要终点的评估显示两组间无显著差异。两种研究治疗方法在蒸发型和非蒸发型DED中同样有效。两种眼部治疗的安全性均良好；仅在使用CTN期间有11例患者出现短暂视力模糊，仅在使用VSE期间有10例患者出现，两种治疗期间均有16例患者出现。
在恢复蒸发型和非蒸发型DED患者的泪膜成分、增加其稳定性以及减少眼表损伤方面，VSE不劣于CTN。
NCT03833882。
