预约演示
更新于：2025-04-06
Dorzolamide Hydrochloride/Timolol Maleate/Brimonidine Tartrate
盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定
更新于：2025-04-06
概要
基本信息
药物类型 小分子化药 |
别名 Brimonidine/dorzolamide/timolol、Krytantek PF、PRO-122 + [2] |
作用方式 激动剂、抑制剂、拮抗剂 |
作用机制 ADRA2激动剂(肾上腺素能受体α-2家族激动剂)、CAs抑制剂(碳酸酐酶家族抑制剂)、β-adrenoceptors拮抗剂(β-肾上腺素能受体家族拮抗剂) |
治疗领域 |
非在研适应症 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C10H17ClN2O4S3 |
InChIKeyOSRUSFPMRGDLAG-QMGYSKNISA-N |
CAS号130693-82-2 |
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关联
9
项与 盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定 相关的临床试验NCT06177678
A Randomized, Open-label, Active-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of TFC-003 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
NCT04702789
Phase IV Clinical Study to Compare the Efficacy of the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination to the Krytantek Ofteno PF® Plus Gaap Ofteno PF® Combination, in Primary Open Angle Glaucoma or Ocular Hypertension Patients.
NCT03966365
Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
100 项与 盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定 相关的临床结果
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100 项与 盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定 相关的转化医学
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100 项与 盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定 相关的专利（医药）
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1
项与 盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定 相关的文献（医药）2018-06-01Ophthalmology and therapy3区 · 医学
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
3区 · 医学
ArticleOA
作者: Jiménez-Román, Jesús ; Muñoz-Villegas, Patricia ; Leñero-Córdova, Rubén ; Davila-Villarreal, Jaime ; Gómez-Aguayo, Francisco ; Paczka, José A ; Baiza-Durán, Leopoldo ; Hartleben, Curt ; García-Velez, Francisco ; Olvera-Montaño, Oscar
Abstract:
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).
100 项与 盐酸多佐胺/马来酸噻吗洛尔/酒石酸溴莫尼定 相关的药物交易
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外链
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 青光眼 | 墨西哥 | 2007-09-01 | |
| 高眼压症 | 墨西哥 | 2007-09-01 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 开角型青光眼 | 临床3期 | - | 2016-04-01 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 24 | (PRO-122) | 壓顧壓齋衊窪廠積願選 = 顧淵觸繭蓋製願顧製獵 壓鏇艱餘壓糧膚鹽淵鏇 (夢範繭憲壓積膚鹹網積, 襯淵餘壓襯鹹餘顧鏇艱 ~ 廠網膚壓顧衊淵鑰膚衊) 更多 | - | 2019-12-13 | ||
(Krytantek Ofteno®) | 壓顧壓齋衊窪廠積願選 = 鹹齋築憲衊艱鹹衊餘顧 壓鏇艱餘壓糧膚鹽淵鏇 (夢範繭憲壓積膚鹹網積, 鏇顧壓範蓋鏇蓋衊襯壓 ~ 遞淵繭鑰鹹壓構憲願衊) 更多 | ||||||
临床2期 | 124 | Timolol+Brimonidine+Dorzolamide (A (Triple Therapy)) | 醖淵構醖醖鬱鏇顧鏇餘(鬱網範憲選簾鏇選觸製) = 鏇築襯窪鹽顧膚齋選範 醖簾顧鏇餘糧糧構艱鹹 (鏇範顧網醖願鏇獵醖膚, 2.6) 更多 | - | 2019-08-01 | ||
timolol+dorzolamide (B (Doble Therapy)) | 醖淵構醖醖鬱鏇顧鏇餘(鬱網範憲選簾鏇選觸製) = 糧選餘壓淵構壓窪憲鑰 醖簾顧鏇餘糧糧構艱鹹 (鏇範顧網醖願鏇獵醖膚, 2.2) 更多 |
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