OBJECTIVE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of a preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel) compared with preserved bimatoprost 0.01% (PB 0.01%).
METHODS: Phase III, international, multicenter, randomized, 2-parallel group, investigator-masked, 3-month treatment duration.
METHODS: Patients with glaucoma or ocular hypertension were randomized after a 7-week run-in/washout period to receive once-daily PFB 0.01% gel (n=236) or PB 0.01% (n=249) for 3 months. The primary efficacy measure was changed from baseline in IOP at week 12. Safety measures included adverse events (AEs) and assessment of conjunctival hyperemia.
RESULTS: The mean changes from baseline in IOP at week 12 in the PFB 0.01% gel and PB 0.01% were -9.72±2.97 and -9.47±3.06 mm Hg, respectively, at 8 am , -9.41±3.03 and -9.19±3.12 mm Hg at 10 am , and -8.99±3.36 and -8.54±3.44 mm Hg at 4 pm . Noninferiority of PFB 0.01% gel to PB 0.01% was demonstrated at week 12 based on predetermined criteria (upper 95% CI margin of 1.5 mmHg at all time points). The most frequently reported AE was conjunctival hyperemia; 13 (5.5%) patients with PFB 0.01% gel and 17 (6.8%) patients with PB 0.01%. The percentage of patients experiencing a worsening from baseline in conjunctival hyperemia score was lower with PFB 0.01% gel compared to PB 0.01% at week 6 (20.1% vs. 29.3%, respectively) and week 12 (18.3% vs. 30.4%, respectively).
CONCLUSIONS: PFB 0.01% ophthalmic gel has the same efficacy in lowering IOP as PB 0.01% and demonstrated less aggravation of conjunctival hyperemia at weeks 6 and 12.
目的:评价不含防腐剂的0.01%比马前列素眼用凝胶(PFB0.01%凝胶)与保存的0.01%比马前列素(PB0.01%)相比,降低眼压(IOP)的疗效和安全性。
方法:第三阶段,国际,多中心,随机化,2平行组,调查员-蒙面,3个月的治疗时间。
方法:患有青光眼或高眼压的患者在7周的磨合/冲洗期后随机接受每日一次的0.01%PFB凝胶(n=236)或0.01%PB(n=249),持续3个月。在第12周,主要疗效指标从IOP的基线变化。安全性措施包括不良事件(AE)和结膜充血的评估。
结果:PFB0.01%凝胶和PB0.01%凝胶在12周时IOP相对于基线的平均变化分别为-9.72±2.97和-9.47±3.06mmHg,分别,早上8点,上午10点-9.41±3.03和-9.19±3.12mmHg,下午4点-8.99±3.36和-8.54±3.44mmHg。基于预定标准(在所有时间点均为1.5mmHg的95%CI上限),在第12周证明PFB0.01%凝胶对PB0.01%的非劣效性。最常见的AE是结膜充血;13例(5.5%)患者为PFB0.01%凝胶,17例(6.8%)患者为PB0.01%。与第6周的PB0.01%相比,PFB0.01%凝胶的结膜充血评分从基线恶化的患者百分比较低(20.1%vs.29.3%,分别)和第12周(18.3%与30.4%,分别)。
结论:0.01%PFB眼用凝胶在降低IOP方面具有与0.01%PB相同的功效,并且在第6周和第12周时结膜充血的加重较少。