Abstract：
BACKGROUND: The purpose of this study is to assess the real-life efficacy and tolerance of a new preservative-free, surfactant-free latanoprost (PFSF-LAT) formulation.
METHODS: Retrospective, multicentre, non-comparative, observational study in patients with ocular hypertension or open angle glaucoma, naïve or non-naïve to previous intraocular pressure (IOP)-lowering treatment, and treated for at least 3 months with the study eye drop. IOP for worse eye, ocular signs and symptoms, and concomitant use of artificial tears were collected at study drug initiation and at last visit under treatment. Reasons for discontinuing the study eye drop (if relevant) and investigators\' satisfaction were also assessed.
RESULTS: In the per protocol population (103 eyes; 63 naïve, 39 switched, 1 not classified because of missing data), IOP decreased significantly (p < 0.001) from 21.6 ± 5.0 mmHg at baseline to 16.1 ± 3.5 mmHg at the end of the study (mean reduction of - 5.5 ± 4.6 mmHg; - 25.5%). IOP in naïve patients was significantly improved, with a mean reduction of 7.1 mmHg (- 30.7%), which was within expected latanoprost IOP-lowering effect. Interestingly, in previously treated patients, switching to PFSF-LAT also allowed for a further 2.9 mmHg decrease in IOP (p < 0.001). The incidence of ocular side effects at study initiation was significantly (p < 0.001) reduced from 31.1% to 11.3% in the overall population, and from 65.0% to 7.5% in switched patients. This included conjunctival hyperaemia and superficial punctate keratitis (from 42.5% to 2.5% and from 37.5% to 2.5% in switched patients, respectively). According to investigators, tolerance and efficacy of the study eye drop were satisfactory or very satisfactory in 98.1% and 83.2% of patients, respectively.
CONCLUSIONS: PFSF-LAT is an efficient treatment for patients with glaucoma with an improved tolerance profile. It can be considered as initial therapy in naïve patients or in patients with poor ocular tolerance to previous IOP-lowering eye drops.
METHODS: Retrospective, multicentre, non-comparative, observational study in patients with ocular hypertension or open angle glaucoma, naïve or non-naïve to previous intraocular pressure (IOP)-lowering treatment, and treated for at least 3 months with the study eye drop. IOP for worse eye, ocular signs and symptoms, and concomitant use of artificial tears were collected at study drug initiation and at last visit under treatment. Reasons for discontinuing the study eye drop (if relevant) and investigators\' satisfaction were also assessed.
RESULTS: In the per protocol population (103 eyes; 63 naïve, 39 switched, 1 not classified because of missing data), IOP decreased significantly (p < 0.001) from 21.6 ± 5.0 mmHg at baseline to 16.1 ± 3.5 mmHg at the end of the study (mean reduction of - 5.5 ± 4.6 mmHg; - 25.5%). IOP in naïve patients was significantly improved, with a mean reduction of 7.1 mmHg (- 30.7%), which was within expected latanoprost IOP-lowering effect. Interestingly, in previously treated patients, switching to PFSF-LAT also allowed for a further 2.9 mmHg decrease in IOP (p < 0.001). The incidence of ocular side effects at study initiation was significantly (p < 0.001) reduced from 31.1% to 11.3% in the overall population, and from 65.0% to 7.5% in switched patients. This included conjunctival hyperaemia and superficial punctate keratitis (from 42.5% to 2.5% and from 37.5% to 2.5% in switched patients, respectively). According to investigators, tolerance and efficacy of the study eye drop were satisfactory or very satisfactory in 98.1% and 83.2% of patients, respectively.
CONCLUSIONS: PFSF-LAT is an efficient treatment for patients with glaucoma with an improved tolerance profile. It can be considered as initial therapy in naïve patients or in patients with poor ocular tolerance to previous IOP-lowering eye drops.
摘要：
背景：这项研究的目的是评估一种新型无防腐剂的现实生活中的功效和耐受性，不含表面活性剂的拉坦前列素(PFSF-LAT)制剂。
方法：回顾性，多中心,非比较性,高眼压或开角型青光眼患者的观察性研究，对先前的眼内压（IOP）降低治疗幼稚或非幼稚，并用研究滴眼液治疗至少3个月。较差眼睛的IOP，眼部体征和症状，在研究药物开始时和在治疗期间的最后一次访视时收集人工泪液的同时使用。停止研究滴眼剂的原因（如果相关）和研究者的满意度也进行了评估。
结果：在每个方案人群中（103眼；63天真的，39开关，1由于缺少数据而未分类)，IOP从基线时的21.6±5.0mmHg显著降低(p<0.001)至研究结束时的16.1±3.5mmHg(平均降低-5.5±4.6mmHg;-25.5%)。初治患者的眼压明显改善，平均降低7.1mmHg(-30.7%)，在预期的拉坦前列素降低IOP的作用范围内。有趣的是,在以前接受过治疗的患者中，转换为PFSF-LAT还允许IOP进一步降低2.9mmHg(p<0.001)。在整个人群中，研究开始时眼部副作用的发生率从31.1％显着（p<0.001）降低到11.3％。转换患者的比例从65.0%降至7.5%。这包括结膜充血和浅表点状角膜炎（在转换患者中从42.5%到2.5%，从37.5%到2.5%，分别)。根据调查人员的说法,研究滴眼液的耐受性和疗效在98.1%和83.2%的患者中令人满意或非常满意，分别。
结论：PFSF-LAT是青光眼患者的有效治疗方法，耐受性改善。它可以被认为是初治患者或对先前降低IOP的滴眼液的眼睛耐受性差的患者的初始治疗。
方法：回顾性，多中心,非比较性,高眼压或开角型青光眼患者的观察性研究，对先前的眼内压（IOP）降低治疗幼稚或非幼稚，并用研究滴眼液治疗至少3个月。较差眼睛的IOP，眼部体征和症状，在研究药物开始时和在治疗期间的最后一次访视时收集人工泪液的同时使用。停止研究滴眼剂的原因（如果相关）和研究者的满意度也进行了评估。
结果：在每个方案人群中（103眼；63天真的，39开关，1由于缺少数据而未分类)，IOP从基线时的21.6±5.0mmHg显著降低(p<0.001)至研究结束时的16.1±3.5mmHg(平均降低-5.5±4.6mmHg;-25.5%)。初治患者的眼压明显改善，平均降低7.1mmHg(-30.7%)，在预期的拉坦前列素降低IOP的作用范围内。有趣的是,在以前接受过治疗的患者中，转换为PFSF-LAT还允许IOP进一步降低2.9mmHg(p<0.001)。在整个人群中，研究开始时眼部副作用的发生率从31.1％显着（p<0.001）降低到11.3％。转换患者的比例从65.0%降至7.5%。这包括结膜充血和浅表点状角膜炎（在转换患者中从42.5%到2.5%，从37.5%到2.5%，分别)。根据调查人员的说法,研究滴眼液的耐受性和疗效在98.1%和83.2%的患者中令人满意或非常满意，分别。
结论：PFSF-LAT是青光眼患者的有效治疗方法，耐受性改善。它可以被认为是初治患者或对先前降低IOP的滴眼液的眼睛耐受性差的患者的初始治疗。
