三种前列腺素类药物降眼压效果比较

目的比较拉坦前列素、曲伏前列素和贝美前列素三种前列腺素类药物的降眼压效果。方法选取原发性开角型青光眼和高眼压症患者,拉坦前列素组51例(51眼),曲伏前列素组24例(24眼),贝美前列素组27例(27眼),分别使用相应滴眼液,均为每日1次,共观察4周,测量用药前后的眼压值。结果三组患者用药4周后眼压均有明显下降,拉坦前列素组在8:30测得平均眼压从(24.57±3.68)mmHg(1 mmHg=0.133 kPa)降至(15.29±2.67)mmHg,下降幅度(用药前后眼压差值/用药前眼压值)为37.8%;曲伏前列素组从(24.54±2.95)mmHg降至(16.29±3.11)mmHg,下降幅度为33.6%;贝美前列素组从(25.41±3.63)mmHg降至(16.00±4.45)mmHg,下降幅度为37.0%。用药前及用药后三组间眼压值比较,差异均无显著性(分别为F=0.579、P=0.562;F=0.868、P=0.423)。结论拉坦前列素、曲伏前列素、贝美前列素滴眼液对于原发性开角型青光眼和高眼压症患者都有明显、持久的降眼压作用,且降眼压作用相互间没有明显差异。     

四种前列腺素类药物的降眼压疗效和耐受性对比研究

目的　探讨四种前列腺素类药物治疗原发性开角型青光眼（primary open-angle glaucoma，POAG）的疗效和耐受性差异。方法　采用随机平行试验，64例(128眼)POAG患者随机分成4组，分别使用贝美前列素(贝美前列素组)、拉坦前列素（拉坦前列素组）、曲伏前列素（曲伏前列素组）和他氟前列素（他氟前列素组）滴眼液治疗，观察并比较4组患者用药前和用药后1个月、3个月和6个月的眼压、眼部检查和眼表疾病指数（ocular surface disease index，OSDI）评分。结果　贝美前列素组用药前眼压为（26.1±6.2）mmHg（1 kPa=7.5 mmHg），用药后1个月、3个月和6个月眼压分别为（17.1±3.4）mmHg、（15.6±4.2）mmHg、（15.5±2.9）mmHg，与用药前比较，差异均有统计学意义（t=17.408、13.016、12.352，均为P＜0.001）。拉坦前列素组用药前眼压为（24.7±2.4）mmHg，用药后1个月、3个月和6个月眼压分别为（16.3±3.0）mmHg、（17.0±3.8）mmHg、（17.4±2.6）mmHg，与用药前比较，差异均有统计学意义（t=12.238、13.365、16.140，均为P＜0.001）。曲伏前列素组用药前眼压为（24.4±1.9）mmHg，用药后1个月、3个月和6个月眼压分别为（16.3±2.0）mmHg、（17.4±1.3）mmHg、（14.9±1.1）mmHg，与用药前比较，差异均有统计学意义（t=12.109、14.451、11.732，均为P＜0.001）。他氟前列素组用药前眼压为（25.2±2.3）mmHg，用药后1个月、3个月和6个月眼压分别为（17.2±3.1）mmHg、（17.0±2.1）mmHg、（18.1±2.4）mmHg，与用药前比较，差异均有统计学意义（t=10.540、16.129、14.006，均为P＜0.001）。拉坦前列素组患者睫毛增长和虹膜变色的发生率最高，4组患者的结膜充血和角膜炎的发生率相似。用药6个月后患者的OSDI评分贝美前列素组（21.8±11.1）分、拉坦前列素组（32.1±24.1）分、曲伏前列素组（10.7±5.7）分、他氟前列素组（25.6±6.3）分，曲伏前列素组患者的OSDI评分显著低于其他3组，差异均有统计学意义（均为P＜0.05）。结论　四种前列腺素类药物均能显著降低POAG患者眼压，曲伏前列素耐受性较好，拉坦前列素的耐受性最差。     

曲伏前列素滴眼液(速为坦)治疗原发性开角型青光眼和高眼压症的临床研究

目的观察曲伏前列素滴眼液(速为坦)降眼压效果及安全性。方法采用随机、单盲、平行对照试验,选取原发性开角型青光眼和高眼压症患者,试验组入选24例(24只眼)滴用曲伏前列素滴眼液,对照组入选23例(23只眼)滴用拉坦前列素滴眼液(适利达),均为每日1次,共观察4周。观察的指标包括眼压、视力、血压、脉搏、眼部症状和体征以及不良反应。结果1试验组平均日间眼压从(2483±297)mmHg(1mmHg=0133kPa)降至(1613±292)mmHg,最大下降幅度为352%;对照组从(2396±362)mmHg降至(1614±297)mmHg,最大下降幅度为326%。2用药后试验组和对照组结膜充血均有明显增加,试验组的眼痒明显重于对照组,但都不妨碍继续用药。未发现其他眼部改变和全身副作用。结论曲伏前列素滴眼液对控制原发性开角型青光眼和高眼压症的眼压是有效和安全的,可望成为理想的一线抗青光眼药物。     

曲伏前列素滴眼液治疗原发性开角型青光眼和高眼压症

目的：研究曲伏前列素滴眼液治疗原发性开角型青光眼和高眼压症的降眼压效果及安全性。方法：随机选取2013-03/2016-03我院收治的原发性开角型青光眼和高眼压症患者80例80眼,依据不同治疗方法分为两组：曲伏前列素滴眼液组( n=40)和拉坦前列素滴眼液组(n=40),对两组患者的临床疗效、视力、散光度、眼压及不良反应发生情况进行统计分析。结果：曲伏前列素滴眼液组患者治疗的总有效率95%(38/40)显著高于拉坦前列素滴眼液组80%(32/40),差异有统计学意义(P<0.05)。曲伏前列素滴眼液组患者治疗后视力显著高于拉坦前列素滴眼液组,差异有统计学意义(P<0.05),散光度、眼压均显著低于拉坦前列素滴眼液组,差异有统计学意义(P<0.05),不良反应发生率25%(10/40)显著低于拉坦前列素滴眼液组53%(21/40),差异有统计学意义(P<0.05)。结论：曲伏前列素滴眼液治疗原发性开角型青光眼和高眼压症比拉坦前列素滴眼液具有较好的降眼压效果及较高的安全性。     

曲伏前列素治疗超声乳化术后的残余慢性闭角型青光眼

目的 观察曲伏前列素滴眼液用于超声乳化白内障吸除术后的残余慢性闭角型青光眼的降眼压效果.方法 回顾性观察超声乳化术后眼压控制不满意的慢性闭角型青光眼15例(15只眼).测量日眼压曲线后给予每晚1次0.004%曲伏前列素滴眼液滴眼.分别于用药1周、4周、8周时测量日眼压曲线,比较用药前后的眼压峰值及眼压波动幅度.结果 用药前平均眼压峰值(23.83±3.74)mm Hg(1 mm Hg=0.133kPa),用药1周后眼压峰值平均为(15.25±3.71)mm Hg,眼压下降幅度36.0%,眼压峰值下降明显,差异有统计学意义(P<0.01).用药后1周眼压波动幅度下降,差异有统计学意义(P<0.01).用药后眼压控制平稳,未见全身及局部严重不良反应.结论 曲伏前列素滴眼液是治疗超声乳化术后残余慢性闭角型青光眼的安全、有效药物.     

国产和进口拉坦前列素滴眼液治疗开角型青光眼及高眼压症的疗效及成本比较

目的:观察国产拉坦前列素滴眼液降眼压效果及安全性,研究进口和国产拉坦前列素滴眼液的成本—效果比。方法:采用随机、单盲、平行对照试验,选取原发性开角型青光眼和高眼压症患者,18例18眼滴用国产拉坦前列素滴眼液,14例14眼滴用进口拉坦前列素滴眼液(适利达),均每日1次,共4wk。观察眼压、视力、血压、脉搏、眼部症状和体征以及不良反应。并采用疗效观察和成本—效果分析方法对进口与国产拉坦前列素滴眼液进行经济学评价。结果:治疗4wk,验证组平均日间眼压从(24.0±3.6)mmHg(1mmHg=0.133kPa)降至(16.1±3.0)mmHg,最大下降幅度为32.9%;对照组从(24.8±3.0)mmHg降至(16.1±2.9)mmHg,最大下降幅度为35.1%。两组用药前后眼压相比均显著差异(P<0.05);各时间点两组间眼压相比均无统计学差异(P>0.05)。用药后验证组和对照组结膜充血均有明显增加,但不妨碍继续用药。未发现其他眼部改变和全身副作用。两组成本分别为119元、70元(P<0.05);眼压下降幅度分别为35%,33%(P>0.05);成本—效果比分别为3.39,2.11;进口组相对于国产组的增量成本—效果比为22.2。结论:进口与国产拉坦前列素滴眼液都能有效地降低开角型青光眼及高眼压症患者的眼内压,且安全、耐受。两组治疗开角型青光眼及高眼压症的效果相近,但国产品是更经济的选择。     

局部应用前列腺素类药物对中央角膜厚度改变的影响

目的:分析曲伏前列素、拉坦前列素和贝美前列素用药后对中央角膜厚度的影响。方法:采用回顾性临床病例对照研究,60例68眼随机分为3组,其中曲伏前列素组20例22眼,拉坦前列素组20例25眼,贝美前列素组20例21眼。测量用药前及用药6mo后的中央角膜厚度。结果:三组用药后平均中央角膜厚度与用药前比较均明显变薄,曲伏前列素组从525±36.45μm下降至510±27.87μm(t=8.11,P<0.05),拉坦前列素组从530±26.65μm下降至512±22.27μm(t=5.62,P<0.05),贝美前列素组从534±47.35μm下降至516±19.56μm(t=5.62,P<0.05)。用药后6mo,三组间平均中央角膜厚度比较无明显差别(F=0.205,P=0.544)。结论:局部应用前列腺素类药物可以使中央角膜厚度变薄。     

拉坦前列素、曲伏前列素和噻吗洛尔治疗原发性开角型青光眼的疗效比较分析

目的：比较拉坦前列素、曲伏前列素及噻吗洛尔滴眼液治疗原发性开角型青光眼（ POAG）的效果。方法将收治的120例患者随机分为A、B、C组,每组均为40例,其中A 组患者给予拉坦前列素滴眼液;B组患者给予曲伏前列素滴眼液;C组患者给予马来酸噻吗洛尔滴眼液,A、B组均为每天晚上约20：00给药1次,每次1滴,疗程为4周,C组为每天早上约08：00给药1次,每次1滴,疗程为4周。结果三组患者治疗前比较,眼压无统计学差异（ P ＞0．05）,三组患者用药治疗4周眼压值均有显著下降,用药前后差异具有统计学意义（ P ＜0．05）;拉坦前列素和曲伏前列素两种滴眼液组间治疗无显著性差异（ P ＞0．05）,但与噻吗洛尔治疗分别进行组间效果比对具有显著性差异（ P ＜0．05）。结论拉坦前列素、曲伏前列素及噻吗洛尔滴眼液治疗POAG在一个疗程内（4周）均能有效降低眼压,疗效持久,且两种前列素降眼压作用明显优于噻吗洛尔滴眼液治疗效果。     

国产与进口拉坦前列素滴眼液降眼压作用的短期效果比较

目的 比较国产与进口拉坦前列素滴眼液的短期降眼压效果。设计 随机、开放、平行对照的临床研究。 研究对象  原发性开角型青光眼患者和高眼压症患者42例。方法 对上述患者按所用药物的不同依随机表法分为A、B两组。A组28例（28眼）,滴用国产拉坦前列素滴眼液（特力洁）,B组14例（14眼）,滴用进口拉坦前列素滴眼液（适利达）,均为每日1次,每次1滴,共28天。受试者于入组当日及用药后第28天8:00、11:00、14:00、16:00测眼压,第7、14、21天则于8:00测眼压。眼压测量采用Goldmann压平眼压计,测量3次取平均值。裂隙灯显微镜观察角膜、虹膜、晶状体情况。主要指标  眼压值。结果 A组用药前眼压为（23.99±1.51）mm Hg, 用药后1～4周眼压分别为（18.04±1.27）mm Hg、（17.75±1.43）mm Hg、（17.63±1.50）mm Hg、（17.49±1.47）mm Hg,用药后眼压明显下降,与用药前相比差异有统计学意义（F=105.72,P=0.000）。B组用药前眼压为（24.37±1.55）mm Hg,用药后1～4周眼压分别为（17.91±1.35）mm Hg、（17.71±1.39）mm Hg、（17.55±1.34）mm Hg、（17.44±1.17）mm Hg,与用药前相比,用药后眼压明显下降,差异有统计学意义（F=67.85 P=0.000）。A、B两组用药前眼压比较无显著性差异（P=0.43）,用药后1～4周两组眼压比较无显著性差异（P值分别为0.76、0.93、0.86、0.89）。入组当日8:00、11:00、14:00、16:00  A、B两组眼压之间的比较无显著性差异（P值分别为0.46、0.44、0.50、0.31）,用药后28天8:00、11:00、14:00、16:00  A、B两组眼压之间的比较无显著性差异（P值分别为0.89、0.85、0.94、0.98）。用药28天时两组患者角膜、虹膜、晶状体均无异常改变。结论  本文的小样本、短期研究显示,国产拉坦前列素与进口拉坦前列素均能有效降低原发性开角型青光眼及高眼压症患者的眼压,两者之间的降眼压效果无显著差异。（眼科, 2012, 21: 111-114）     

国产拉坦前列素滴眼液对POAG和高眼压症的降眼压疗效及安全性多中心研究

背景 拟前列腺素滴眼液是治疗青光眼,尤其是开角型青光眼的一线药物,但价格较高.国产的类似药物拉坦前列素滴眼液已应用于临床,但大样本、多中心的疗效和安全性评价鲜有报道. 目的 采用多中心观察性研究方法评价国产拉坦前列素滴眼液治疗原发性开角型青光眼（POAG）和高眼压症的临床疗效及安全性.方法 采用多中心观察性研究方法,按照统一的纳入标准和排除标准在中国5个地区25家医院纳入确诊的POAG及高眼压症患者576例837眼,其中POAG患者524例755眼,高眼压症患者52例82眼.本研究经广州军区武汉总医院伦理委员会批准实施,所有患者均知情同意并签署知情同意书.患者每晚用0.05 g/L国产拉坦前列素滴眼液点眼1次,用药3个月,主要观察指标为眼压控制情况,次要观察指标为视力、血压、脉搏、眼部症状和体征,采用用药前后自身对照的方法评价药物的疗效及安全性.结果 患者用药后1、2、3个月的眼压分别为（19.66±5.46）、（19.59±7.86）和（19.35±5.03）mmHg（1 mmHg=0.133 kPa）,均较用药前的（28.36±7.86） mmHg明显下降,各时间点眼压值的总体差异有统计学意义（F=748.325,P=0.000）,其中治疗后各时间点的眼压值均明显低于治疗前,差异均有统计学意义（P＜0.001）;用药后1、2、3个月眼压的平均下降幅度分别为（30.43±7.18）％、（30.19±8.72）％和（30.71±9.90）％.治疗后1、2、3个月显效率分别为95.70％、91.76％和88.05％.用药后3个月出现结膜持续充血者占13％,但不妨碍继续用药,未发现与药物相关的全身及其他眼部不良反应.结论 国产拉坦前列素滴眼液可有效降低眼压,安全性好,为治疗开角型青光眼及高眼压症提供了新的选择.     

The effect of latanoprost, bimatoprost, and travoprost on circadian variation of intraocular pressure in patients with open-angle glaucoma

PURPOSE: To evaluate the efficacy of latanoprost, bimatoprost, and travoprost given in the evening over the 24-hour curve in newly diagnosed open-angle glaucoma patients. METHODS: This 8-week, randomized, parallel group, masked evaluator study compared the efficacy of once daily administration of latanoprost 0.005%, bimatoprost 0.03%, and travoprost 0.004% ophthalmic solutions. After enrollment at baseline, 48 patients were randomized to 3 treatment groups: latanoprost (n=17), bimatoprost (n=16), and travoprost (n=15). At baseline and 8 weeks of therapy, masked evaluators measured intraocular pressure (IOP) at 8 AM, 10 AM, 1 PM, 4 PM, 8 PM, 11 PM, and 3 AM. RESULTS: Baseline mean IOP levels were similar across the groups. By week 8, reductions were observed in all 3 groups (P<0.001 for each). Travoprost-treated patients' IOP levels were reduced 8.7 and 8.1 mm Hg at 8 and 10 AM, respectively. Latanoprost-treated patients experienced 4.8 and 5.3 mm Hg reductions, whereas bimatoprost-treated patients experienced 5.5 and 4.9 mm Hg reductions at these time points. The amount of IOP reduction seen at 8 and 10 AM in travoprost group was significantly higher when compared with latanoprost and bimatoprost-treated group (P<0.001). CONCLUSIONS: Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in open-angle glaucoma patients. On the basis of our data, the IOP reduction of these drugs is indistinguishable within statistical parameters.     

A comparison of latanoprost,bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week,randomized, masked-evaluator multicenter study

PURPOSE: To Internet Advance publication at ajo.com Feb 13, 2003. compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost, bimatoprost, and travoprost in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). DESIGN: Interventional study. METHODS: This 12-week, randomized, parallel-group study was conducted at 45 US sites. Previously treated patients with OAG or OH and an IOP > or =23 mm Hg in one or both eyes after washout received either latanoprost 0.005%, bimatoprost 0.03%, or travoprost 0.004% once daily in the evening. At baseline and after 6 and 12 weeks of therapy, masked evaluators measured IOP in triplicate at 8:00 AM, 12 noon, 4:00 PM, and 8:00 PM, and masked investigators graded conjunctival hyperemia before the 8:00 AM IOP measurement. The primary efficacy outcome measure was change between baseline and Week 12 in the 8:00 AM IOP (time of peak drug effect). RESULTS: In all, 410 of 411 randomized patients were included in intent-to-treat analyses (latanoprost, 136; bimatoprost, 136; travoprost, 138). Baseline mean 8:00 AM IOP levels were similar (P =.772); by week 12, reductions were observed in all 3 groups (P <.001 for each). Adjusted (ANCOVA) reductions in mean IOP at 8:00 AM were similar (P =.128) as were those at 12 noon, 4:00 PM, and 8:00 PM. Fewer latanoprost-treated patients reported ocular adverse events (P <.001, latanoprost vs bimatoprost), fewer reported hyperemia (P =.001, latanoprost vs bimatoprost), and average hyperemia scores were lower at week 12 (P =.001, latanoprost vs bimatoprost). CONCLUSIONS: Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in OAG and OH patients. Latanoprost exhibited greater ocular tolerability.     

A six-month randomized clinical trial comparing the intraocular pressure-lowering efficacy of bimatoprost and latanoprost in patients with ocular hypertension or glaucoma

PURPOSE: To compare the intraocular pressure (IOP)-lowering efficacy and safety of topical bimatoprost 0.03% with latanoprost 0.005%. DESIGN: Multicenter, randomized, investigator-masked clinical trial. METHODS: After washout of glaucoma medications, ocular hypertension or glaucoma patients were randomly assigned to once-daily bimatoprost 0.03% (n = 133) or latanoprost 0.005% (n = 136) for 6 months. The primary outcome measure was mean change from baseline IOP (8 AM, 12 PM, 4 PM). Secondary measures included mean IOP, ophthalmologic examination, adverse events, and the percentage of patients reaching specific target IOPs. RESULTS: Mean change from baseline IOP was significantly greater for bimatoprost patients than for latanoprost patients at all measurements on each study visit; 1.5 mm Hg greater at 8 AM (P <.001), 2.2 mm Hg greater at 12 PM (P <.001), and 1.2 mm Hg greater at 4 PM (P =.004) at month 6. At the end of the study, the percentage of patients achieving a > or = 20% IOP decrease was 69% to 82% with bimatoprost and 50% to 62% with latanoprost (P < or = .003). In addition, the distribution of patients achieving target pressures in each range (< or = 13 to < or = 15 mm Hg, >15 to < or = 18 mm Hg, and > 18 mm Hg) showed that bimatoprost produced lower target pressures compared with latanoprost at all times measured (P < or = .026). Few patients were discontinued for adverse events (6 on bimatoprost; 5 on latanoprost). On ophthalmologic examination, conjunctival hyperemia (P <.001) and eyelash growth (P =.064) were more common in bimatoprost patients. CONCLUSIONS: Bimatoprost is more effective than latanoprost in lowering IOP. Both drugs were well tolerated, with few discontinuations for adverse events.     

Inter-visit intraocular pressure range: an alternative parameter for assessing intraocular pressure control in clinical trials

PURPOSE: To evaluate whether inter-visit intraocular pressure (IOP) range, which reflects extreme and potentially damaging IOP fluctuations, provides additional information on IOP control compared to mean IOP. DESIGN: Post hoc analysis of Xalatan/Lumigan/Travatan study data, a masked-evaluator, randomized, parallel-group comparison of 12-week efficacy of latanoprost, bimatoprost, and travoprost in open-angle glaucoma/ocular hypertension patients. METHODS: Pretreatment inter-visit IOP range defined as highest IOP minus lowest IOP at screening, safety check, and baseline (six measurements); posttreatment inter-visit IOP range defined as highest IOP minus lowest IOP at weeks two, six, and 12 or early termination (nine measurements). Ranges dichotomized as "high" (>6 mm Hg) vs "low" (< or =6 mm Hg). RESULTS: Included were 410 patients (latanoprost, 136; bimatoprost, 136; travoprost, 138). Each resulted in significant mean IOP range reductions during 12 weeks. Pretreatment inter-visit IOP range was associated with African-American race, male gender, and presence of visual field defect (P < .05 for all). Percentages with high pretreatment inter-visit IOP ranges were comparable across treatments (63% to 64%). High posttreatment inter-visit IOP range was seen in 21% (28/136), 28% (38/136), and 36% (50/138) of latanoprost, bimatoprost, and travoprost groups, respectively (P = .016, overall; P = .005, latanoprost vs travoprost). High posttreatment inter-visit IOP range was associated with African-American race, high pretreatment inter-visit IOP range, and treatment with travoprost vs latanoprost (P < .05 for all). CONCLUSIONS: Given that high inter-visit IOP range is associated with risk factors for glaucomatous damage and that such differences cannot be evaluated using mean IOPs, inter-visit IOP range may be another useful approach to assessing IOP control in clinical trials.     

Prostaglandin analogs and blood-aqueous barrier integrity: a flare cell meter study

PURPOSE: To study, with an objective method, inflammation of the anterior segment of the glaucomatous eye after treatment with latanoprost, travoprost and bimatoprost. MATERIALS AND METHODS: Sixty patients with chronic open-angle glaucoma aged between 38 and 76 years (mean 64.0 +/- 12.2) were randomly assigned to latanoprost 0.005, travoprost 0.004 and bimatoprost 0.03%. The study period lasted 6 months. Intraocular pressure (IOP) was measured every 2 weeks. We studied the intraocular inflammation before and after 3 and 6 months of therapy with an instrument composed of a He-Ne laser beam system, a photomultiplier mounted on a slitlamp microscope and a computer. This flare meter allows objective determination of the flare and the number of cells in the aqueous of the anterior chamber. RESULTS: At the baseline, IOP was 26.4 +/- 3.6 mm Hg. After 3 months of treatment, mean IOP in the latanoprost group was 17.9 +/- 0.3 mm Hg (p < 0.001) with a mean cellularity of 12.638 +/- 3.284 photons/ms (p < 0.001). The travoprost group had an IOP of 17.2 +/- 0.3 mm Hg (p < 0.001) with a cellularity of 9.719 +/- 1.927 photons/ms (0.001). Finally, IOP in the bimatoprost group was 17.6 +/- 0.5 mm Hg (p < 0.001) with a cellularity of 6.138 +/- 1.475 photons/ms (p < 0.032). After 6 months of treatment, IOP in the latanoprost group was 18.1 +/- 0.3 (p < 0.001), in the travoprost group 17.3 +/- 0.3 (p < 0.001) and in the bimatoprost group 17.7 +/- 0.5 mm Hg (p < 0.001), whereas cellularity was 11.838 +/- 3.218 (p < 0.001), 8.950 +/- 3.692 (p < 0.001) and 7.617 +/- 2.603 photons/ms (p < 0.001), respectively. After 3 months, the travoprost (p < 0.013) and the bimatoprost groups (p < 0.001) had less flare compared with the latanoprost group and this remained so even at 6 months. When we compared the travoprost group with the bimatoprost group, we found significantly less flare at 3 months in the bimatoprost group (p < 0.001) but not at 6 months (p < 0.246). CONCLUSIONS: The flare meter analysis shows that the eyes treated with bimatoprost and travoprost have a less significantly broken blood-aqueous barrier and their anterior chamber is also significantly less inflamed.     

Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension

PURPOSE: This study evaluated the safety and intraocular pressure-lowering efficacy of two concentrations of travoprost (0.0015% and 0.004%) compared with latanoprost 0.005% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. METHODS: Eight hundred one patients with open-angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.0015%, travoprost 0.004%, latanoprost 0.005%, or timolol 0.5%. The efficacy and safety of travoprost (0.0015% and 0.004%) daily was compared with latanoprost daily and timolol twice daily for a period of 12 months. RESULTS: Travoprost was equal or superior to latanoprost and superior to timolol with mean intraocular pressure over visits and time of day ranging from 17.9 to 19.1 mm Hg (travoprost 0.0015%), 17.7 to 19.1 mm Hg (travoprost 0.004%), 18.5 to 19.2 mm Hg (latanoprost), and 19.4 to 20.3 mm Hg (timolol). For all visits pooled, the mean intraocular pressure at 4 PM for travoprost was 0.7 mm Hg (0.0015%, P =.0502) and 0.8 mm Hg (0.004%, P =.0191) lower than for latanoprost. Travoprost 0.004% was more effective than latanoprost and timolol in reducing intraocular pressure in black patients by up to 2.4 mm Hg (versus latanoprost) and 4.6 mm Hg (versus timolol). Based on a criterion of 30% or greater intraocular pressure reduction from diurnal baseline or intraocular pressure 17 mm Hg or less, travoprost 0.0015% and 0.004% had an overall response to treatment of 49.3% and 54.7%, respectively, compared with 49.6% for latanoprost and 39.0% for timolol. Iris pigmentation change was observed in 10 of 201 of patients (5.0%) receiving travoprost 0.0015%, six of 196 of patients (3.1%) receiving travoprost 0.004%, 10 of 194 of patients (5.2%) receiving latanoprost, and none of the patients receiving timolol (0 of 196). The average ocular hyperemia score was less than 1 on a scale of 0 to 3, indicating that on average patients experienced between none/trace and mild for all treatment groups. There were no serious, unexpected, related adverse events reported for any therapy. CONCLUSIONS: Travoprost (0.0015% and 0.004%), a highly selective, potent prostaglandin F (FP) receptor agonist, is equal or superior to latanoprost and superior to timolol in lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In addition, travoprost 0.004% is significantly better than either latanoprost or timolol in lowering intraocular pressure in black patients. Travoprost is safe and generally well tolerated in the studied patient population.     

The safety and efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution

PURPOSE: To compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination ophthalmic solution (Trav/Tim) to its components travoprost 0.004% ophthalmic solution, TRAVATAN, (Trav) and timolol 0.5% ophthalmic solution (Tim) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Randomized multicenter, double-masked, active-controlled, parallel group study. METHODS: Two hundred sixty-three patients with open-angle glaucoma or ocular hypertension were randomized to receive Trav/Tim once daily AM (and vehicle PM), Trav once daily PM (and vehicle AM), or Tim twice daily (AM and PM). Efficacy and safety were compared across treatment groups over 3 months. RESULTS: Trav/Tim produced a mean IOP decrease from baseline of 1.9 mm Hg to 3.3 mm Hg more than Tim, with a significant decrease in mean IOP at each of the nine study visits (P < or = .003). Trav/Tim decreased mean IOP by 0.9 mm Hg to 2.4 mm Hg more than Trav, with a significant decrease in mean IOP at seven of the nine study visits (P < or = .05). The adverse event profile for Trav/Tim was comparable to Trav or Tim alone. CONCLUSIONS: Over the 3 months of treatment, Trav/Tim produced clinically relevant IOP reductions in patients with open-angle glaucoma or ocular hypertension that were greater than those produced by either Trav or Tim alone. The clinical results that Trav/Tim was safe and well tolerated with an incidence of adverse events was comparable to the results of Trav or Tim alone. Trav/Tim provides both more effective IOP reduction than its components and the benefits of once-daily dosing.     

Travoprost compared with other prostaglandin analogues or timolol in patients with open-angle glaucoma or ocular hypertension: meta-analysis of randomized controlled trials

BACKGROUND: It is still uncertain whether travoprost has comparable or better efficacy compared with other prostaglandin analogues or timolol in patients with open-angle glaucoma or ocular hypertension. The authors performed a meta-analysis of randomized controlled trials to evaluate the incidence of reported side-effects and intraocular pressure (IOP)-lowering effect of travoprost versus other prostaglandin analogues (latanaprost, bimatoprost, unoprostone) or timolol. METHODS: Systematic literature retrieval was conducted in Pubmed, EMBASE, Chinese Bio-medicine Database and Cochrane Controlled Trials Register to identify the potentially relevant randomized controlled trials. The statistical analysis was performed by RevMan 4.1 software that was provided by the Cochrane Collaboration. The outcome measures were the incidence of reported side-effects (hyperaemia, iris pigmentation, eyelash changes) and mean IOP pooled over treatment visits. RESULTS: In total, 12 articles involving 3048 patients with open-angle glaucoma or ocular hypertension were included in this meta-analysis. The combined results showed that travoprost 0.004% was more effective than timolol or travoprost 0.0015% in lowering IOP, but not more effective than bimatoprost or latanoprost. Travoprost 0.004% caused a higher percentage of hyperaemia than timolol, latanoprost, or travoprost 0.0015%. There was an increased incidence of pigmentation with travoprost than timolol. Travoprost 0.004% caused a higher percentage of eyelash changes than timolol, latanoprost, or travoprost 0.0015%. CONCLUSION: According to data available, travoprost is more effective than timolol in lowering IOP in patients with open-angle glaucoma or ocular hypertension. Compared with other prostaglandin analogues, travoprost appears to be equivalent to bimatoprost and latanoprost. Although a limited number of local side-effects were reported, no serious treatment-related side-effects were reported.     

Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy

PURPOSE: To compare the safety and efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. METHODS: The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either travoprost 0.004% with BAC (n=346), or travoprost 0.004% without BAC (n=344) dosed once-daily each evening. Patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM, and 4 PM were taken at study visits on week 2, week 6, and month 3. RESULTS: Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg for travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were within +/-0.8 mm Hg at 9 of 9 study visits and times in both the per protocol and intent-to-treat data sets. Adverse events and the number of patients discontinued owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with travoprost 0.004% without BAC and travoprost 0.004% with BAC, respectively. CONCLUSION: Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.