一项0.5%噻吗洛尔+0.2%溴莫尼定+2.0%多佐胺固定复方无防腐剂滴眼液与0.5%噻吗洛尔+0.2%溴莫尼定+2.0%多佐胺固定复方治疗原发性开角型青光眼病情控制患者的III期随机临床试验
A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma.
作者信息
Gómez-Aguayo Francisco, Paczka José A, Leñero-Córdova Rubén, Jiménez-Román Jesús, Davila-Villarreal Jaime, Hartleben Curt, Baiza-Durán Leopoldo, Olvera-Montaño Oscar, García-Velez Francisco, Muñoz-Villegas Patricia
机构信息
Private Practice, Guadalajara, Jalisco, Mexico.
Unidad de Diagnóstico Temprano del Glaucoma, Zapopan, Jalisco, Mexico.
出版信息
Ophthalmol Ther. 2018 Jun;7(1):145-156. doi: 10.1007/s40123-018-0128-8. Epub 2018 Apr 21.
INTRODUCTION
The aim of this prospective crossover study was to evaluate the non-inferiority of PRO-122 (a preservative-free fixed combination) compared with 0.5% timolol + 0.2% brimonidine + 2.0% dorzolamide fixed combination (KOF) by evaluating its efficacy, tolerability and safety in subjects with controlled primary open-angle glaucoma (POAG) previously treated with KOF for at least 2 months.
METHODS
In a prospective, crossover, randomized, double-masked multicenter study, patients previously treated with KOF were randomly assigned to receive either PRO-122 or KOF for 30 days. On day 31, the A sequence changed to KOF, while the B sequence received PRO-122. All patients remained in the protocol for 30 additional days for a total of 60 days. The main efficacy endpoint was maintaining the controlled intraocular pressure (IOP). The safety and tolerability of both products were assessed by the presence of adverse events (AEs), ocular findings, a questionnaire on ocular comfort and the VF-14 index.
RESULTS
A total of 51 patients participated. After application of PRO-122 twice a day, its efficacy was demonstrated through maintenance of the controlled IOP in patients previously controlled with KOF. The crossover between PRO-122 and KOF and vice versa, after 30 days of use, did not affect IOP control. PRO-122 was shown not to be inferior to KOF in maintaining IOP at control levels. The safety of both drugs is similar, as neither presented drug-related AEs or differences regarding safety issues. The tolerability of the two medications-evaluated by ocular findings, the questionnaire on ocular comfort and the VF-14 index-was also determined to be similar.
CONCLUSIONS
The controlled IOP in patients with controlled POAG treated with PRO-122 was maintained both in relation to the initial controlled IOP of the study and when compared with KOF in the B sequence. Finally, the treatment with PRO-122 demonstrated similar safety and tolerability to KOF.
FUNDING
Laboratorios Sophia, S.A. de C.V. (Zapopan, Jalisco, México).
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03257813 (registered retrospectively).
引言
这项前瞻性交叉研究的目的是，通过评估PRO-122（一种无防腐剂的固定复方制剂）在先前接受0.5%噻吗洛尔+0.2%溴莫尼定+2.0%多佐胺固定复方制剂（KOF）治疗至少2个月的原发性开角型青光眼（POAG）病情得到控制的受试者中的疗效、耐受性和安全性，来评价其相对于KOF的非劣效性。
方法
在一项前瞻性、交叉、随机、双盲多中心研究中，先前接受KOF治疗的患者被随机分配接受PRO-122或KOF治疗30天。在第31天，A组换用KOF，而B组接受PRO-122。所有患者继续按照方案治疗30天，共计60天。主要疗效终点是维持眼压得到控制。通过不良事件（AE）的发生情况、眼部检查结果、眼部舒适度问卷和VF-14指数来评估两种产品的安全性和耐受性。
结果
共有51例患者参与。每天两次应用PRO-122后，通过在先前用KOF控制病情的患者中维持眼压得到控制，证明了其疗效。在使用30天后，PRO-122与KOF之间的交叉使用（反之亦然）并未影响眼压控制。结果显示，在将眼压维持在控制水平方面，PRO-122不劣于KOF。两种药物的安全性相似，因为两者均未出现与药物相关的不良事件，在安全性问题上也没有差异。通过眼部检查结果、眼部舒适度问卷和VF-14指数评估，两种药物的耐受性也相似。
结论
在用PRO-122治疗的POAG病情得到控制的患者中，相对于研究初始时控制的眼压以及与B组中的KOF相比，眼压均得到维持。最后，PRO-122治疗显示出与KOF相似的安全性和耐受性。
资助
Laboratorios Sophia, S.A. de C.V.（墨西哥哈利斯科州萨波潘）。
试验注册
ClinicalTrials.gov标识符：NCT03257813（回顾性注册）。
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