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Abstract：
BACKGROUND: Primary open-angle glaucoma (POAG), often associated with increased intraocular pressure (IOP), can lead to permanent damage of the optic nerve, concomitant visual field loss, and blindness. Latanoprost, a prostaglandin F2α analogue, reduces IOP and is used to treat glaucoma. In this clinical trial, we evaluated the efficacy of Latanoprost Polpharma, a generic preservative-free latanoprost 0.05 mg/ml eye drops solution, in lowering IOP when compared to the originator Xalatan® (latanoprost 0.005% ophthalmic solution, Pfizer).
METHODS: This was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18-75 years) with open-angle glaucoma or ocular hypertension.
RESULTS: Forty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04 ± 2.14 mmHg or 7.17 ± 2.11 mmHg was found after treatment with test or reference product, respectively (N = 44). In the intention to treat analysis, the reduction was 7.29 ± 2.53 mmHg (95% CI: 6.55-8.04) or 7.43 ± 2.78 mm Hg (95%CI: 6.61-8.24) after treatment with test or reference product, respectively (N = 47). There were no serious adverse events.
CONCLUSIONS: Latanoprost Polpharma was shown to be non-inferior to Xalatan®. Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life.
BACKGROUND: The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41,779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018) (clinical trial identification number: 848,300,144/0103/1 - POP03; IND number/EudraCT number: 2018-001727-39).
METHODS: This was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18-75 years) with open-angle glaucoma or ocular hypertension.
RESULTS: Forty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04 ± 2.14 mmHg or 7.17 ± 2.11 mmHg was found after treatment with test or reference product, respectively (N = 44). In the intention to treat analysis, the reduction was 7.29 ± 2.53 mmHg (95% CI: 6.55-8.04) or 7.43 ± 2.78 mm Hg (95%CI: 6.61-8.24) after treatment with test or reference product, respectively (N = 47). There were no serious adverse events.
CONCLUSIONS: Latanoprost Polpharma was shown to be non-inferior to Xalatan®. Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life.
BACKGROUND: The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41,779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018) (clinical trial identification number: 848,300,144/0103/1 - POP03; IND number/EudraCT number: 2018-001727-39).
摘要：
背景：原发性开角型青光眼（POAG），通常与眼内压（IOP）升高有关，会导致视神经的永久性损伤,伴随的视野丧失，和失明。拉坦前列素,前列腺素F2α类似物，降低IOP，用于治疗青光眼。在这个临床试验中,我们评估了拉坦前列素Polpharma的疗效，通用的无防腐剂拉坦前列素0.05mg/ml滴眼液，与鼻祖Xalatan®(拉坦前列素0.005%滴眼液,辉瑞）。
方法：这是第三阶段，多中心,随机化，调查员-蒙面,cross-over,比较,在匈牙利和俄罗斯的5个地点进行了非劣效性试验。主要终点是评估测试产品在第1天(基线)和第29天的平均昼夜IOP的差异与参考产品相比时的非劣效性。次要终点包括疗效，眼公差,安全,和可用性。我们招募了患有开角型青光眼或高眼压的成年患者（18-75岁）。
结果：49名患者被随机分组并接受至少一个剂量的测试或参考产品。用试验产品或参比产品治疗后，平均每日眼压下降几乎相同，为7.04±2.14mmHg或7.17±2.11mmHg。分别（N=44）。在对待分析的意图中，用试验产品或参比产品处理后，下降幅度为7.29±2.53mmHg（95%CI：6.55-8.04）或7.43±2.78mmHg（95CI：6.61-8.24），（N=47）。无严重不良事件发生。
结论：拉坦前列素Polpharma被证明不劣于Xalatan®。两种研究产品同样具有良好的耐受性和安全性。数据显示了在充血症的严重程度和眼部不适的缓解速度方面有利于测试产品的趋势。拉坦前列素Polpharma,不含防腐剂，也避免了苯扎氯铵的细胞毒性，副作用可能会影响患者的依从性并降低生活质量。
背景：该研究获得了美国国家药学与营养研究所（OGYEI，OGYEI/41,779-11/2018）和匈牙利临床药理学伦理委员会（KFEB）以及俄罗斯联邦卫生部（俄罗斯卫生部）在研究开始之前（642/25.12.2018）（临床试验标识号：848,300,144/0103/1-POP03；IND编号/EudraCT编号：2018-001727-39）。
方法：这是第三阶段，多中心,随机化，调查员-蒙面,cross-over,比较,在匈牙利和俄罗斯的5个地点进行了非劣效性试验。主要终点是评估测试产品在第1天(基线)和第29天的平均昼夜IOP的差异与参考产品相比时的非劣效性。次要终点包括疗效，眼公差,安全,和可用性。我们招募了患有开角型青光眼或高眼压的成年患者（18-75岁）。
结果：49名患者被随机分组并接受至少一个剂量的测试或参考产品。用试验产品或参比产品治疗后，平均每日眼压下降几乎相同，为7.04±2.14mmHg或7.17±2.11mmHg。分别（N=44）。在对待分析的意图中，用试验产品或参比产品处理后，下降幅度为7.29±2.53mmHg（95%CI：6.55-8.04）或7.43±2.78mmHg（95CI：6.61-8.24），（N=47）。无严重不良事件发生。
结论：拉坦前列素Polpharma被证明不劣于Xalatan®。两种研究产品同样具有良好的耐受性和安全性。数据显示了在充血症的严重程度和眼部不适的缓解速度方面有利于测试产品的趋势。拉坦前列素Polpharma,不含防腐剂，也避免了苯扎氯铵的细胞毒性，副作用可能会影响患者的依从性并降低生活质量。
背景：该研究获得了美国国家药学与营养研究所（OGYEI，OGYEI/41,779-11/2018）和匈牙利临床药理学伦理委员会（KFEB）以及俄罗斯联邦卫生部（俄罗斯卫生部）在研究开始之前（642/25.12.2018）（临床试验标识号：848,300,144/0103/1-POP03；IND编号/EudraCT编号：2018-001727-39）。
