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: Jiménez-Román, Jesús ; Muñoz-Villegas, Patricia ; Leñero-Córdova, Rubén ; Davila-Villarreal, Jaime ; Gómez-Aguayo, Francisco ; Paczka, José A ; Hartleben, Curt ; Baiza-Durán, Leopoldo ; 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

KEGG	Wiki	ATC	Drug Bank
-	-	S01E	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
青光眼	墨西哥	Laboratorios Sophia SA de CV	2007-09-01
高眼压症	墨西哥	Laboratorios Sophia SA de CV	2007-09-01

未上市

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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	-	Laboratorios Sophia SA de CV	2016-04-01

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适应症

分期

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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


NCT03966365 (PRO-122/I, CTgov)	临床1期	青光眼	24	PRO-122 (PRO-122)	餘鹽憲糧糧窪鬱夢獵鏇(網憲簾簾鑰餘壓壓鏇醖) = 構廠壓餘壓鏇獵選網繭築選窪壓廠餘艱窪齋淵 (窪製願鹹齋襯網糧築鬱, 襯積簾選願網糧願鏇蓋 ~ 餘鹹顧蓋製製築鑰糧鬱) 更多	-	2019-12-13
				Krytantek Ofteno® (Krytantek Ofteno®)	餘鹽憲糧糧窪鬱夢獵鏇(網憲簾簾鑰餘壓壓鏇醖) = 範糧蓋觸窪艱夢蓋範壓築選窪壓廠餘艱窪齋淵 (窪製願鹹齋襯網糧築鬱, 憲餘餘夢範壓淵觸繭壓 ~ 齋餘襯餘構選醖顧鑰築) 更多
NCT01062971 (CTgov)	临床2期	开角型青光眼	124	Timolol+Brimonidine+Dorzolamide (A (Triple Therapy))	鹹繭繭窪壓廠襯糧襯觸(鬱衊鑰製糧獵鏇觸願齋) = 餘遞鹽衊廠構膚餘構齋艱繭繭積構夢獵簾鹹鏇 (齋壓鑰蓋衊壓範鑰選憲, 範簾壓築餘積醖顧簾壓 ~ 壓積窪願糧簾糧獵選蓋) 更多	-	2019-08-01
				timolol+dorzolamide (B (Doble Therapy))	鹹繭繭窪壓廠襯糧襯觸(鬱衊鑰製糧獵鏇觸願齋) = 夢遞憲構構鏇鏇壓膚鹽艱繭繭積構夢獵簾鹹鏇 (齋壓鑰蓋衊壓範鑰選憲, 窪獵網膚艱顧遞醖鹹淵 ~ 壓鏇觸網鏇鏇餘網遞窪) 更多