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

The purpose of this study was to explore the efficacy and safety of the weekly intraocular pressure change of the TFC-003 group and the dorzolamid/timolol combination group in patients with primary open-angle glaucoma or ocular hypertension.

开始日期2024-02-01

申办/合作机构

KUKJE PHARMA Co., Ltd.

NCT04702789 / Terminated临床4期

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.

Phase IV randomized, double blind, multicenter, parallel group clinical study to evaluate the efficacy of the combined use of Krytantek Ofteno PF® and Gaap Ofteno PF®, both applied every 12 hours, versus the use of Eliptic Ofteno PF® Plus Gaap Ofteno PF®, both applied every 12 hours, in patients with open angle glaucoma or ocular hypertension during 90 days

开始日期2021-10-19

申办/合作机构

Laboratorios Sophia SA de CV

NCT03966365 / Completed临床1期

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

Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.
Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.
Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.
Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.

开始日期2019-05-02

申办/合作机构

Laboratorios Sophia SA de CV

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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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）

2018-06-01·Ophthalmology 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: Francisco Gómez-Aguayo ; José A Paczka ; Rubén Leñero-Córdova ; Jesús Jiménez-Román ; Jaime Davila-Villarreal ; Curt Hartleben ; Leopoldo Baiza-Durán ; Oscar Olvera-Montaño ; Francisco García-Velez ; Patricia Muñoz-Villegas

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

KEGG	Wiki	ATC	Drug Bank
-	-	S01E	-

研发状态

适应症	最高研发状态	国家/地区	公司
高眼压症	批准上市	墨西哥更多	Laboratorios Sophia SA de CV 更多
青光眼	批准上市	墨西哥更多	Laboratorios Sophia SA de CV 更多
开角型青光眼	临床3期	哥伦比亚更多	Laboratorios Sophia SA de CV 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03257813 (CTgov)	临床3期	开角型青光眼	60	PRO-122 (Sequence A)	- 更多	-	2019-12-09
				PRO-122 (Sequence B)
ISRCTN48477221 (ARVO2009)	N/A	开角型青光眼 \| 青光眼	112	Timolol-Brimonidine-Dorzolamide	(餘艱構鬱淵糧醖艱衊餘) = 鬱夢夢顧餘網壓夢襯網築製壓鏇餘願顧淵鹹鹽 (鹹範鹹壓淵醖繭淵願顧, 2.95)	积极	2009-04-01
				Timolol-Dorzolamide	(餘艱構鬱淵糧醖艱衊餘) = 廠鑰選夢艱鹽願繭蓋網築製壓鏇餘願顧淵鹹鹽 (鹹範鹹壓淵醖繭淵願顧, 3.42)
NCT01737853 (Pubmed \| BMC Ophthalmol)	N/A	开角型青光眼 \| 高眼压症	90	Fixed-combination bimatoprost/timolol	(膚網觸構壓夢鑰壓鏇積) = 鏇範顧遞壓構窪簾艱醖膚齋觸淵艱壓夢憲繭鹹 (醖醖繭膚鑰鏇鹹觸顧遞 ) 更多	-	2014-12-19
				Fixed-combination dorzolamide/brimonidine/timolol	(膚網觸構壓夢鑰壓鏇積) = 鹽廠醖鑰艱製窪淵憲衊膚齋觸淵艱壓夢憲繭鹹 (醖醖繭膚鑰鏇鹹觸顧遞 ) 更多
NCT03966365 (CTgov)	临床1期	青光眼	24	PRO-122 (PRO-122)	鹽遞醖顧襯範築艱膚廠(顧糧艱襯選糧淵獵繭獵) = 鹹積衊築餘壓範齋襯遞淵鏇積範鏇選鬱築積壓 (遞鑰糧淵鬱襯簾獵夢鹽, 構鏇願顧構範齋顧積鏇 ~ 膚糧積繭廠構鏇醖遞憲) 更多	-	2019-12-13
				Krytantek Ofteno® (Krytantek Ofteno®)	鹽遞醖顧襯範築艱膚廠(顧糧艱襯選糧淵獵繭獵) = 衊網夢願蓋衊網網膚願淵鏇積範鏇選鬱築積壓 (遞鑰糧淵鬱襯簾獵夢鹽, 齋顧窪壓艱製獵構衊鏇 ~ 獵鑰選顧糧廠壓淵鏇鹽) 更多