Godfrey David A, Peplinski Lee S, Stewart Jeanette A, Stewart William C
Glaucoma Associates of Texas, Dallas, TX, USA.
Clin Ophthalmol. 2009;3:189-94. doi: 10.2147/opth.s4741. Epub 2009 Jun 2.
To determine the short-term comfort after a single dose of travoprost BAK-free compared to latanoprost in primary open-angle glaucoma or ocular hypertensive patients.
Prospective, double-masked, randomized comparison of two separate active agents dosed once in opposite eyes.
At Visit 1, qualified patients began a glaucoma medicine-free period for three days. At Visit 2, patients were randomly assigned to travoprost BAK-free or latanoprost in opposite eyes. Following dosing in each eye, patients completed a visual analog scale (VAS score, 0-100 mm) at specified time intervals and a comfort survey.
In 54 completed subjects, no difference existed five seconds after dosing, in comfort on the VAS between latanoprost (7.1 +/- 16.2 mm) and travoprost BAK-free (7.8 +/- 16.1 mm, P = 0.53). Also no differences existed between treatments following dosing for discomfort at individual timepoints past five seconds, peak discomfort or the time required to return to baseline comfort (P > 0.05). In addition, the comfort survey demonstrated no difference between products for burning, stinging, foreign body sensation, overall comfort and general acceptance between the products, both for absolute levels and changes from baseline (P > 0.05).
Following a single instillation, both latanoprost and travoprost BAK-free exhibit similar comfort scores.
比较单剂量无苯扎氯铵的曲伏前列素与拉坦前列素用于原发性开角型青光眼或高眼压症患者后的短期舒适度。
前瞻性、双盲、随机比较两种不同活性药物分别滴眼于对侧眼一次的情况。
在第1次就诊时,符合条件的患者开始停用青光眼药物3天。在第2次就诊时,患者被随机分配在对侧眼分别使用无苯扎氯铵的曲伏前列素或拉坦前列素。每只眼滴眼给药后,患者在特定时间间隔完成视觉模拟量表(VAS评分,0 - 100mm)及舒适度调查。
在54例完成研究的受试者中,滴眼给药后5秒时,拉坦前列素(7.1±16.2mm)与无苯扎氯铵的曲伏前列素(7.8±16.1mm,P = 0.53)在VAS舒适度评分上无差异。在给药后5秒后的各个时间点、最大不适程度或恢复至基线舒适度所需时间方面,两种治疗方法之间也无差异(P>0.05)。此外,舒适度调查显示,两种产品在烧灼感、刺痛感、异物感、总体舒适度以及总体接受度方面,无论是绝对水平还是相对于基线的变化,均无差异(P>0.05)。
单次滴注后,拉坦前列素和无苯扎氯铵的曲伏前列素的舒适度评分相似。