Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye.
Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye.
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DOI：
10.1038/eye.2017.73
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发表时间：
2017-10
期刊：
影响因子：
--
通讯作者：
Baudouin C
中科院分区：
文献类型：
--
作者：
Labetoulle M;Chiambaretta F;Shirlaw A;Leaback R;Baudouin C
评估与透明质酸相比，一种联合眼保护剂、羧甲基纤维素和透明质酸（O/CMC/HA）的滴眼剂在减轻症状性中度至重度干眼症方面的安全性和有效性。在这项治疗设盲、随机化研究中，患者滴注1-2滴/眼O/CMC/HA或HA（2-6次/天），持续3个月。主要终点：第35天总体眼染色评分（GOSS）较基线的平均变化。在符合方案人群中检验O/CMC/HA的非劣效性;如果达到，则在意向治疗人群中检验优效性。次要疗效终点：GOSS、眼表疾病指数（OSDI）、Schirmer评分、泪膜破裂时间（TBUT）、角膜/结膜染色、结膜充血、症状和患者/研究者评估较基线的平均变化。两组之间的基线特征相当（每组n=40）。基于两组第35天和第3个月GOSS较基线的降低相似，O/CMC/HA非劣效于（且非上级）HA（P=0.778，第35天，符合方案人群）。总体而言，O/CMC/HA和HA在35天时OSDI、Schirmer评分、TBUT、角膜染色和充血较基线降低相似（P≥0.155）。与HA组（46.2%，P=0.002）相比，O/CMC/HA组在第3个月时更多患者报告较不严重的刺痛/烧灼感、砂质/砂砾感和眼睛疼痛/酸痛（P≤0.039），并且更多患者认为滴管易于使用（87.5%）。两组间的其他患者和研究者评估相似。O/CMC/HA和HA耐受性良好。O/CMC/HA在改善干眼客观体征方面不劣于HA，在主观症状和患者接受度方面具有潜在优势。
To assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic, moderate to severe dry eye, compared with HA. In this investigator-masked, randomised study, patients instilled 1–2 drops/eye of O/CMC/HA or HA (2–6 times/day) for 3 months. Primary endpoint: mean change in Global Ocular Staining Score (GOSS) from baseline at day 35. Noninferiority of O/CMC/HA was tested in the per-protocol population; if achieved, superiority was tested in the intent-to-treat population. Secondary efficacy endpoints: mean change from baseline in GOSS, Ocular Surface Disease Index (OSDI), Schirmer score, tear break-up time (TBUT), corneal/conjunctival staining, conjunctival hyperaemia, symptoms, and patient/investigator assessments. Baseline characteristics were comparable between groups (n=40 each). O/CMC/HA was noninferior (and not superior) to HA based on similar GOSS reductions from baseline at day 35 and month 3 in both groups (P=0.778, day 35, per-protocol population). Overall, O/CMC/HA and HA provided similar reductions in OSDI, Schirmer score, TBUT, corneal staining and hyperaemia from baseline at 35 days (P≥0.155). More patients reported less severe stinging/burning, sandiness/grittiness, and painful/sore eyes at month 3 with O/CMC/HA (P≤0.039), and more rated the dropper bottle easy to use (87.5%), compared with HA (46.2% P=0.002). Other patient and investigator assessments were similar between groups. O/CMC/HA and HA were well tolerated. O/CMC/HA is noninferior to HA in improving objective signs of dry eye, with potential advantages for subjective symptoms and patient acceptance.
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