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Abstract：
CONCLUSIONS: Noninferiority of efficacy was demonstrated for a preservative-free bimatoprost 0.01% compared with BAK-containing bimatoprost 0.01% following a 12-week treatment period in patients with open angle glaucoma or ocular hypertension. Improved tolerability, in particular conjunctival hyperemia, was also observed.
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.
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.
摘要：
结论：在开角型青光眼或高眼压症患者治疗12周后，与含BAK的比马前列素0.01％相比，无防腐剂的比马前列素0.01％的疗效无劣性。提高耐受性，特别是结膜充血，也被观察到了。
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。
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。
