地塞米松/莫西沙星(Dexamethasone/Moxifloxacin) - 药物靶点：Bacterial DNA gyrase x GR x Topoisomerase IV_在研适应症：眼部感染，术后炎症_专利_临床

概要

基本信息

药物类型

小分子化药

别名

MoxiDex Otic、Moxifloxacin/dexamethasone、VIGADEXA

+ [3]

靶点

Bacterial DNA gyrase x GR x Topoisomerase IV

作用机制

细菌DNA旋转酶复合体抑制剂、GR激动剂(糖皮质激素受体激动剂)、拓扑异构酶 IV抑制剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

Alcon Research Ltd.EMS SA (Brazil)

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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结构

分子式C21H25ClFN3O4

InChIKeyIDIIJJHBXUESQI-DFIJPDEKSA-N

CAS号186826-86-8

关联

14

项与地塞米松/莫西沙星相关的临床试验

NCT06352541 / Not yet recruiting临床1期

Phase I Clinical Study, Evaluating Safety and Tolerability of PRO-232 an Ophthalmic Solution, Versus Placebo, When Applied to the Ocular Surface of Ophthalmologically and Clinically Healthy Volunteers.

This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo.

开始日期2024-05-30

申办/合作机构

Laboratorios Sophia SA de CV

CTR20230646 / Completed临床1期

OT-601-C在中国健康受试者中单次、多次给药的药代动力学特征和安全性的Ⅰ期临床研究

观察中国健康受试者单次和多次使用OT-601-C的人体药代动力学特征。评价中国健康受试者单次和多次使用OT-601-C的安全性。

开始日期2023-03-17

申办/合作机构

苏州欧康维视生物科技有限公司

[+1]

NCT01515826 / Withdrawn临床3期

Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery

The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.

开始日期2014-03-01

申办/合作机构

Alcon Research Ltd.

100 项与地塞米松/莫西沙星相关的临床结果

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100 项与地塞米松/莫西沙星相关的转化医学

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100 项与地塞米松/莫西沙星相关的专利（医药）

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2

项与地塞米松/莫西沙星相关的文献（医药）

2023-11-01·Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie

Safety of intracameral application of moxifloxacin and dexamethasone (Vigadexa®) after phacoemulsification surgery.

Article

作者: Parra, Maria Margarita ; Galvis, Virgilio ; Camacho, Paul Anthony ; Polit, María Paz ; Prada, Angelica Maria ; Tello, Alejandro

BACKGROUNDIntracameral antibiotics, such as moxifloxacin and cefuroxime, are safe to corneal endothelial cells and effective prophylaxis of endophthalmitis after cataract surgery. Corneal endothelial cells decrease in density after cataract surgery. Any substance used in the anterior chamber may affect corneal endothelial cells and lead to a greater decrease in density. This study wants to determine the percentage of endothelial cell loss after cataract extraction by phacoemulsification with off-label intracameral injection of moxifloxacin and dexamethasone (Vigadexa®).METHODSAn observational retrospective study was performed. The clinical records of patients undergoing cataract surgery by phacoemulsification plus intracameral injection of Vigadexa® were analyzed. Endothelial cell loss (ECL) was calculated using preoperative and postoperative endothelial cell density. The relation of endothelial cell loss with cataract grade using LOCS III classification, total surgery time, total ultrasound time, total longitudinal power time, total torsional amplitude time, total aspiration time, estimated fluid usage, and cumulative dissipated energy (CDE) was studied using univariate linear regression analysis and logistic regression analysis.RESULTSThe median loss of corneal endothelial cells was 4.6%, interquartile range 0 to 10.4%. Nuclear color and CDE were associated with increased ECL. ECL>10% was associated with age and total ultrasound time in seconds.CONCLUSIONSThe endothelial cell loss after the intracameral use of Vigadexa® at the end of cataract surgery was similar to the reported in other studies of cataract surgery without the use of intracameral prophylaxis for postoperative endophthalmitis (POE). This study confirmed the association of CDE and nuclear opalescence grade with postoperative corneal endothelial cell loss.

2007-01-01·Current Medical Research and Opinion4区 · 医学

Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial

4区 · 医学

Article

作者: Soriano, Eduardo ; Lemes Freitas, Lincoln ; Luisa Höfling-Lima, Ana ; Belfort, Rubens ; Muccioli, Cristina

PURPOSETo compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox) and 0.1% dexamethasone (Maxidex) for the prevention of infection and control of inflammation after cataract surgery.SETTINGThe ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil.METHODSA prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days -2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up.RESULTSThere was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had < or = 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups (p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery.CONCLUSIONTreatment with the combined moxiflox acin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation.

100 项与地塞米松/莫西沙星相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01CA01 S03CA01 S02CA06 D07CB04	-

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
眼部感染	-	Alcon AG	-

未上市

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适应症	最高研发状态	国家/地区	公司	日期
眼部感染	临床2期	中国	杭州民生药业股份有限公司	2024-01-24
眼部感染	临床2期	中国	苏州欧康维视生物科技有限公司	2024-01-24
术后炎症	临床1期	中国	杭州民生药业股份有限公司	2023-03-17
白内障	临床前	-	Alcon Research Ltd.	2014-03-01
感染	临床前	-	Alcon Research Ltd.	2014-03-01
炎症	临床前	-	Alcon Research Ltd.	2014-03-01
急性渗出性中耳炎	临床前	美国	Alcon Research Ltd.	2010-02-01
角膜炎	临床前	美国	Alcon Research Ltd.	2007-12-01

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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


NCT01859702 (CTgov)	临床4期	白内障	36	Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution	衊糧蓋構獵遞衊夢襯鑰(製窪壓鏇積廠遞繭廠範) = 廠窪憲鹽醖衊窪膚繭夢襯願製醖鏇艱願鏇醖遞 (願壓願遞顧鏇鹹齋鹽選, 淵積築齋憲簾獵憲糧鏇 ~ 構獵遞壓餘築壓範窪糧) 更多	-	2013-08-07
NCT00870103 (CTgov)	临床4期	白内障 \| 炎症 \| 感染	64	Vigadexa	糧艱餘築鹽壓鹹淵衊繭(鹹夢齋窪壓遞餘鹽鹹簾) = 窪觸壓壓遞遞簾製鏇顧鬱廠憲淵齋鹹願淵餘鏇 (壓鏇膚糧蓋壓繭膚遞襯, 齋簾繭簾壓鏇夢簾淵鹽 ~ 淵鬱醖襯襯膚網醖範鹽) 更多	-	2010-02-15