Crichton Andrew C, Nixon Donald R, Simonyi Susan, Bhogal Meetu, Sigouin Christopher S, Discepola Marino J, Hutnik Cindy Ml, Baptiste Darryl C, Yan David B
Division of Ophthalmology, University of Calgary, Calgary, AB, Canada.
Private practice, Barrie, ON, Canada.
Clin Ophthalmol. 2014 May 23;8:1031-8. doi: 10.2147/OPTH.S46298. eCollection 2014.
To evaluate the ocular hyperemia and intraocular pressure (IOP)-lowering efficacy of bimatoprost 0.01% in subjects with elevated IOP due to primary open-angle glaucoma (POAG) or ocular hypertension (OHT) in a real-world clinical setting.
This open-label, 12-week, observational study was conducted at 67 centers in Canada. Subjects with elevated IOP due to POAG or OHT instilled bimatoprost 0.01% as monotherapy once daily. Ocular hyperemia was graded by the investigator at baseline, week 6, and week 12 using a standardized photographic 5-point grading scale. Change in IOP from baseline was also evaluated at these time points. This analysis includes the subgroup of 268 subjects who had been previously treated with latanoprost 0.005%, bimatoprost 0.03%, travoprost 0.004%, and travoprost 0.004% with SofZia™ or nonselective beta-adrenergic receptor blockers prior to the study.
After 12 weeks of treatment with 0.01% bimatoprost, ocular hyperemia was graded as none-to-mild hyperemia (grades 0, +0.5, or +1) for 94.1% of subjects and as moderate-to-severe hyperemia (grades +2 or +3) for 5.9%. No statistically significant shifts in ocular hyperemia ratings were observed at week 12 for any of the prior IOP-lowering therapies except bimatoprost 0.03%, in which 20.8% of subjects experienced an improvement. The mean percentage change from baseline IOP at week 12 following the switch to bimatoprost 0.01% monotherapy ranged from -2.3%±17.3% to -26.3%±12.4%. Furthermore, the decreased mean percentage change from baseline IOP was statistically significant across all prior IOP-lowering medications, except for bimatoprost 0.03% at the 6- and 12-week visits and travoprost 0.004% at the 6-week visit.
This observational study demonstrates that bimatoprost 0.01% was well tolerated among POAG and OHT subjects who switched from prior IOP-lowering medication. Furthermore, a switch in ocular hypertensive treatment to bimatoprost 0.01% was associated with an additional 10%-15% reduction in IOP.
在真实临床环境中，评估0.01%比马前列素对因原发性开角型青光眼（POAG）或高眼压症（OHT）导致眼压升高的受试者的眼部充血及降眼压疗效。
这项开放标签、为期12周的观察性研究在加拿大的67个中心进行。因POAG或OHT导致眼压升高的受试者将0.01%比马前列素作为单一疗法每日滴眼一次。研究者在基线、第6周和第12周使用标准化的5分摄影分级量表对眼部充血进行分级。在这些时间点也评估了眼压相对于基线的变化。该分析包括268名在研究前曾用0.005%拉坦前列素、0.03%比马前列素、0.004%曲伏前列素以及含SofZia™的0.004%曲伏前列素或非选择性β-肾上腺素能受体阻滞剂治疗过的受试者亚组。
用0.01%比马前列素治疗12周后，94.1%的受试者眼部充血分级为无至轻度充血（0级、+0.5级或+1级），5.9%的受试者为中度至重度充血（+2级或+3级）。在第12周，除0.03%比马前列素（其中20.8%的受试者病情有所改善）外，其他任何先前的降眼压治疗均未观察到眼部充血分级有统计学意义的变化。转换为0.01%比马前列素单一疗法后，第12周眼压相对于基线的平均变化百分比范围为-2.3%±17.3%至-26.3%±12.4%。此外，除了在第6周和第12周访视时的0.03%比马前列素以及第6周访视时的0.004%曲伏前列素外，所有先前的降眼压药物治疗后，眼压相对于基线的平均变化百分比下降均具有统计学意义。
这项观察性研究表明，从先前的降眼压药物转换过来的POAG和OHT受试者对0.01%比马前列素耐受性良好。此外，将高眼压治疗转换为0.01%比马前列素可使眼压额外降低10%-15%。
