Versura Piera, Profazio Vincenzo, Campos Emilio C
Department of Surgery and Anesthesiology, Section of Ophthalmology, Alma Mater Studiorum University at Bologna, Bologna, Italy.
Clin Ophthalmol. 2008 Sep;2(3):629-35. doi: 10.2147/opth.s3731.
To evaluate the efficacy of Systane((R)) Lubricating Eye Drops in improving the symptoms of moderate ocular dryness.
Fifty subjects with moderate symptoms of ocular dryness were enrolled in this open label study. The mean age of subjects was 57.6 +/- 15.4 years. To be eligible, subjects' tear film break-up time (TFBUT) had to be <10 seconds, and subjects had to have at least one ocular discomfort symptom in addition to dryness. Saline was used for a washout period of 3-5 days. Subjects were re-examined, and those continuing to meet the inclusion criteria were dispensed Systane((R)) and re-examined again after 28 days. At each visit, slitlamp examination was conducted, and ocular discomfort symptoms and TFBUT were evaluated. Subjects rated their overall satisfaction at baseline and on the last visit.
No significant changes in TFBUT or ocular discomfort symptoms were observed after saline use, compared with screening visit. After 28 days of Systane((R)) use there was statistically significant improvement of TFBUT (p = 0.0001) compared with baseline. Subjects experienced significant symptomatic relief for all 6 ocular discomfort symptoms at the endpoint visit.
Systane((R)) effectively relieved the symptoms associated with moderate ocular dryness, with measurable improvement in objective TFBUT, subjective symptoms, and overall satisfaction.
评估思然(Systane((R)))润滑滴眼液改善中度眼干症状的疗效。
五十名有中度眼干症状的受试者参与了这项开放标签研究。受试者的平均年龄为57.6±15.4岁。符合条件的受试者,其泪膜破裂时间(TFBUT)必须<10秒,且除眼干外必须至少有一种眼部不适症状。在3 - 5天的洗脱期使用生理盐水。对受试者进行重新检查,继续符合纳入标准的受试者被给予思然(Systane((R))),并在28天后再次进行检查。每次就诊时,进行裂隙灯检查,并评估眼部不适症状和TFBUT。受试者在基线和最后一次就诊时对总体满意度进行评分。
与筛查就诊相比,使用生理盐水后TFBUT或眼部不适症状未观察到显著变化。使用思然(Systane((R)))28天后,与基线相比TFBUT有统计学显著改善(p = 0.0001)。在终点就诊时,受试者的所有6种眼部不适症状都有显著的症状缓解。
思然(Systane((R)))有效缓解了与中度眼干相关的症状,在客观TFBUT、主观症状和总体满意度方面都有可测量的改善。