Fundación Oftalmológica Nacional, Bogotá, Colombia.
Asociación Para Evitar la Ceguera en México IAP, CDMX, México.
Curr Eye Res. 2021 Jul;46(7):919-929. doi: 10.1080/02713683.2020.1849733. Epub 2020 Dec 8.
: To evaluate the efficacy of a preservative free sodium hyaluronate/chondroitin sulfate ophthalmic solution (SH/CS-PF) in patients with dry eye disease (DED).: This was a randomized phase IV, multicentric, prospective, double-blind clinical trial. Intent-to-treat (ITT) and per-protocol (PP) analyses were performed. Patients were assigned to receive either SH/CS-PF, Systane® Ultra (PEG/PG) or Systane® Ultra PF (PEG/PG-PF) for 90 days. A total of 326 patients were included in the ITT, and 217 in the PP analysis. Efficacy endpoints were goblet cell density, Nelson's grades (conjunctival impression cytology), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), and Schirmer's test. Other parameters included were tolerability, measured by the ocular symptomatology; and safety, measured through corneal staining, intraocular pressure, visual acuity and adverse events.: In the ITT, there was a significant increase in mean goblet cell density in all treatments compared with their baseline (28.4% vs 21.4% and 30.8%), without difference between arms ( = .159). Eyes exposed to SH/CS-PF, PEG/PG and PEG/PG-PF showed Grade 0-I squamous metaplasia (85.5%, 87.9% and 93.2%, respectively). Similar improvements were observed for TBUT (1.24 ± 2.3s vs 1.27 ± 2.4s and 1.39 ± 2.3s) and OSDI scores at day 90 (-8.81 ± 8.6 vs -7.95 ± 9.2 and -8.78 ± 9.8), although no significant intergroup difference was found. Schirmer's test also presented improvement compared to baseline (1.38 ± 4.9 vs 1.50 ± 4.7 and 2.63 ± 5.9), with a significantly higher variation for PEG/PG-PF. There were no significant differences between treatments for any tolerability and safety parameter, nor between ITT and PP analyses for any outcome.: The topical application of SH/CS-PF is as effective, safe and well tolerated as that of PEG/PG or PEG/PG-PF. The results suggest that SH/CS-PF may lead to normalization of clinical parameters and symptom alleviation in patients treated for DED.
评估一种不含防腐剂的透明质酸钠/硫酸软骨素滴眼液（SH/CS-PF）在干眼症（DED）患者中的疗效。
这是一项随机的 IV 期、多中心、前瞻性、双盲临床试验。进行意向治疗（ITT）和符合方案（PP）分析。患者被分配接受 SH/CS-PF、Systane®Ultra（PEG/PG）或 Systane®Ultra PF（PEG/PG-PF）治疗 90 天。共有 326 名患者被纳入 ITT 分析，217 名患者纳入 PP 分析。疗效终点为杯状细胞密度、纳尔逊评分（结膜印迹细胞学）、泪膜破裂时间（TBUT）、眼表疾病指数（OSDI）和泪液分泌试验。其他参数包括通过眼部症状评估的耐受性，以及通过角膜染色、眼压、视力和不良事件评估的安全性。
在 ITT 中，与基线相比，所有治疗组的平均杯状细胞密度均显著增加（分别为 28.4%、21.4%和 30.8%），但各组之间无差异（ =.159）。接受 SH/CS-PF、PEG/PG 和 PEG/PG-PF 治疗的眼睛显示 0-I 级鳞状化生（分别为 85.5%、87.9%和 93.2%）。TBUT（1.24 ± 2.3s 比 1.27 ± 2.4s 和 1.39 ± 2.3s）和 OSDI 评分在第 90 天（-8.81 ± 8.6 比-7.95 ± 9.2 和-8.78 ± 9.8）也有类似的改善，尽管组间没有显著差异。与基线相比，泪液分泌试验（1.38 ± 4.9 比 1.50 ± 4.7 和 2.63 ± 5.9）也有所改善，PEG/PG-PF 的变化明显更高。在任何耐受性和安全性参数方面，治疗之间没有显著差异，在任何结果方面，ITT 和 PP 分析之间也没有显著差异。
SH/CS-PF 的局部应用与 PEG/PG 或 PEG/PG-PF 一样有效、安全且耐受良好。结果表明，SH/CS-PF 可能导致 DED 患者的临床参数正常化和症状缓解。
