Waduthantri Samanthila, Yong Siew Sian, Tan Chien Hua, Htoon Hla Myint, Tong Louis
Singapore Eye Research Institute, Singapore.
Optom Vis Sci. 2012 Nov;89(11):1647-53. doi: 10.1097/OPX.0b013e31826cfc41.
To investigate the efficacy of a lubricant eye drop containing gelling agent in adult Chinese dry eye patients.
This is a prospective, randomized, double-masked, double-arm, parallel, interventional single-site clinical study. Thirty Chinese dry eye patients were randomized into two arms, 15 patients each, receiving lubricant eye drops either containing hydroxypropyl-guar (HP-guar) gelling agent (Systane Ultra) or no gelling agent (Refresh Tears), 1 drop, four times a day for 6 weeks. The main outcome measure was global symptom score (based on severity and frequency of dry eye symptoms on a visual analog scale) at weeks 1, 3, and 6. Secondary outcomes were changes in sectoral corneal fluorescein staining, tear break-up time, and Schirmer's I test results from pretreatment level.
Both groups showed significant improvement in symptoms from baseline (p < 0.001). There was no significant difference in the global symptom score at weeks 1, 3, and 6 between the two groups. There was significantly more severe corneal fluorescein staining in the HP-guar group at baseline in the left nasal (p = 0.023) and left inferior (p = 0.046) zones, but no difference in staining was observed between the two arms at weeks 1, 3, and 6. There were no differences in Schirmer's test results or tear break-up time (final and pretreatment) between the two groups (p > 0.05).
Both lubricant eye drops, with or without HP-guar gelling agent, benefit patients in relieving dry eye symptoms. There was no difference in the efficacy of these drugs in terms of improving symptoms and altering objective signs of dry eye.
研究含胶凝剂的润滑眼药水对成年中国干眼症患者的疗效。
这是一项前瞻性、随机、双盲、双臂、平行、介入性单中心临床研究。30名中国干眼症患者被随机分为两组,每组15名,分别接受含羟丙基瓜尔胶(HP-瓜尔胶)胶凝剂的润滑眼药水(思然倍润)或不含胶凝剂的润滑眼药水(瑞珠滴眼液),每天4次,每次1滴,持续6周。主要观察指标为第1、3和6周时的总体症状评分(基于视觉模拟量表上干眼症症状的严重程度和频率)。次要观察指标为扇形角膜荧光素染色、泪膜破裂时间以及泪液分泌试验结果相对于治疗前水平的变化。
两组患者的症状均较基线水平有显著改善(p < 0.001)。两组在第1、3和6周时的总体症状评分无显著差异。HP-瓜尔胶组在基线时左鼻侧(p = 0.023)和左下侧(p = 0.046)区域的角膜荧光素染色明显更严重,但在第1、3和6周时两组之间的染色情况无差异。两组之间泪液分泌试验结果或泪膜破裂时间(最终与治疗前)无差异(p > 0.05)。
含或不含HP-瓜尔胶胶凝剂的润滑眼药水均可使患者在缓解干眼症状方面获益。这些药物在改善症状和改变干眼症客观体征方面的疗效无差异。