地塞米松/聚维酮碘(Dexamethasone/Povidone Iodine) - 药物靶点：GR_在研适应症：结膜炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

PVP-I/dexamethasone、Povidone iodine/dexamethasone

+ [2]

靶点

GR

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

眼部疾病

在研适应症

结膜炎

非在研适应症

腺病毒性结膜炎腺病毒科感染细菌性结膜炎+ [1]

原研机构

CLS Pharma SAS

在研机构

CLS Pharma SAS

非在研机构

Shire Plc

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C6H9I2NO

InChIKeyCPKVUHPKYQGHMW-UHFFFAOYSA-N

CAS号25655-41-8

关联

8

项与地塞米松/聚维酮碘相关的临床试验

CTRI/2019/04/018758 / Terminated临床3期

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Adenoviral Conjunctivitis

开始日期2019-04-30

申办/合作机构

Shire Human Genetic Therapies, Inc.

[+1]

NCT03004924 / Completed临床3期

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

开始日期2017-03-29

申办/合作机构

Shire Plc

NCT02998554 / Terminated临床3期

A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Adenoviral Conjunctivitis

The purpose of this study is to determine if an investigational treatment is effective compared with placebo in the treatment of adults and children with adenoviral conjunctivitis.

开始日期2017-03-28

申办/合作机构

Shire Plc

100 项与地塞米松/聚维酮碘相关的临床结果

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100 项与地塞米松/聚维酮碘相关的转化医学

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100 项与地塞米松/聚维酮碘相关的专利（医药）

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2

项与地塞米松/聚维酮碘相关的文献（医药）

2020-07-01·American Journal of Ophthalmology

A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis

Article

作者: Wang, Yuemei ; Gross, Robert D ; Raizman, Michael B ; Mallick, Sushanta ; Ta, Christopher N ; Joshi, Sunir ; Segal, Bruce

PURPOSETo evaluate the efficacy and safety of a topical ophthalmic suspension combination of povidone-iodine 0.6% (PVP-I) and dexamethasone 0.1% (DEX) for infectious and inflammatory components of bacterial conjunctivitis.DESIGNRandomized, double-masked, multicenter, phase 3 clinical trial.METHODSSubjects of all ages (those <3 months had to be full-term) with a diagnosis of bacterial conjunctivitis were randomized 3:1:3 to either PVP-I/DEX, PVP-I alone, or placebo. The primary endpoint was clinical resolution in the study eye, and the key secondary efficacy endpoint was bacterial eradication, both at the day 5 visit. Adverse events (AEs) were documented at all visits.RESULTSOverall, 753 subjects were randomized (intent-to-treat [ITT] population; PVP-I/DEX [n = 324]; PVP-I [n = 108]; placebo [n = 321]); mean and standard deviation (SD) age was 44.3 (22.9) years, and most were female (61.2%) and white (78.1%). In all treatment groups, mean treatment compliance was >98%. The modified ITT population for the efficacy analysis comprised 526 subjects. In the study eye at the day 5 visit, clinical resolution was achieved by 50.5% (111/220) subjects in the PVP-I/DEX group vs 42.8% (95/222) in the placebo group (P = .127), and bacterial eradication was achieved by 43.3% (94/217) and 46.8% (102/218), respectively (P = .500). Treatment-emergent AEs were experienced by 32.8% (106/323), 39.8% (43/108), and 19.0% (61/321) of subjects in the safety population treated with PVP-I/DEX, PVP-I, and placebo, respectively (most mild in severity).CONCLUSIONIn this study, PVP-I/DEX did not demonstrate additional benefit in clinical efficacy compared with placebo in subjects with bacterial conjunctivitis.

2011-01-21·Investigative Opthalmology & Visual Science2区 · 医学

Clinical and Antiviral Efficacy of an Ophthalmic Formulation of Dexamethasone Povidone-Iodine in a Rabbit Model of Adenoviral Keratoconjunctivitis

2区 · 医学

ArticleOA

作者: Bhattacharjee, Partha S. ; Liang, Bo ; Capriotti, Joseph A. ; Foster, Timothy P. ; Clement, Christian ; Hill, James M. ; Hobden, Jeffery A. ; Thompson, Hilary W. ; Mahmud, Rashed ; Kumar, Manish

PURPOSETo determine the efficacy of a new formulation of topical dexamethasone 0.1%/povidone-iodine 0.4% (FST-100) in reducing clinical symptoms and infectious viral titers in a rabbit model of adenoviral keratoconjunctivitis.METHODSRabbit corneas were inoculated bilaterally with 2×10(6) plaque-forming-units (PFU) of adenovirus type 5 (Ad5) after corneal scarification. Animals were randomized 1:1:1:1 (five rabbits per group) to FST-100, 0.5% cidofovir, tobramycin/dexamethasone (Tobradex; Alcon Laboratories, Fort Worth, TX) ophthalmic suspension, and balanced salt solution (BSS; Alcon Laboratories). Treatment began 12 hours after viral inoculation and continued for 7 consecutive days. The eyes were clinically scored daily for scleral inflammation (injection), ocular neovascularization, eyelid inflammation (redness), friability of vasculature, inflammatory discharge (pus), and epiphora (excessive tearing). Eye swabs were collected daily before treatment for the duration of the study. Virus was eluted from the swabs and PFU determined by titration on human A549 cells, according to standard procedures.RESULTSThe FST-100 treatment resulted in significantly lower clinical scores (P<0.05) than did the other treatments. The 0.5% cidofovir exhibited the most ocular toxicity compared with FST-100, tobramycin/dexamethasone, and balanced salt solution treatments. FST-100 and 0.5% cidofovir significantly (P<0.05) reduced viral titers compared with tobramycin/dexamethasone or balanced salt solution.CONCLUSIONSFST-100 was the most efficacious in minimizing the clinical symptoms of adenovirus infection in rabbit eyes. FST-100 and 0.5% cidofovir were both equally effective in reducing viral titers and decreasing the duration of viral shedding. By providing symptomatic relief in addition to reducing infectious virus titers, FST-100 should be a valuable addition to treatment of epidemic adenoviral keratoconjunctivitis.

100 项与地塞米松/聚维酮碘相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
结膜炎	临床3期	-	CLS Pharma SAS	-
腺病毒性结膜炎	临床前	英国	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	印度	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	意大利	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	匈牙利	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	秘鲁	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	西班牙	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	奥地利	Shire Plc	2017-03-27
腺病毒性结膜炎	临床前	南非	Shire Plc	2017-03-27
腺病毒性结膜炎	药物发现	德国	Shire Plc	2017-03-27

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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


NCT02998554 (CTgov)	临床3期	腺病毒性结膜炎	156	SHP640 (SHP640)	鹽憲願顧襯憲顧齋鹹繭(積夢構顧襯醖觸鬱醖獵) = 憲築築憲窪網願範簾繭鹹鑰觸簾願齋糧製顧壓 (淵繭簾範蓋鏇鏇鏇簾衊, 鏇構壓顧鏇糧鏇範糧膚 ~ 窪觸鑰選膚膚願廠構夢) 更多	-	2020-05-29
				Placebo (Placebo)	鹽憲願顧襯憲顧齋鹹繭(積夢構顧襯醖觸鬱醖獵) = 繭顧蓋繭糧築網鬱願鏇鹹鑰觸簾願齋糧製顧壓 (淵繭簾範蓋鏇鏇鏇簾衊, 獵願衊網鑰獵窪鑰淵膚 ~ 願鹹壓網襯鹹衊餘觸積) 更多
NCT02998541 (CTgov)	临床3期	腺病毒性结膜炎	219	SHP640 (SHP640)	繭遞壓醖選鹹繭醖膚顧(餘網鑰鑰淵簾範齋鹹夢) = 鬱糧衊遞餘襯鬱醖餘鬱餘憲繭鹹夢膚膚淵範積 (艱餘醖淵壓夢範遞醖鏇, 範鏇鹽衊衊鏇積積憲鑰 ~ 艱構選淵築膚網鹽襯選) 更多	-	2020-05-27
				PVP-I 0.6% (PVP-I 0.6%)	繭遞壓醖選鹹繭醖膚顧(餘網鑰鑰淵簾範齋鹹夢) = 廠窪範壓襯夢衊築簾糧餘憲繭鹹夢膚膚淵範積 (艱餘醖淵壓夢範遞醖鏇, 選壓鹽齋願鏇構廠範鹽 ~ 顧繭蓋鏇顧壓網構觸顧) 更多
NCT03004924 (CTgov)	临床3期	细菌性结膜炎	753	SHP640 (SHP640)	窪壓鏇衊製蓋壓積遞鹽(網積蓋觸鹽顧製艱簾衊) = 鏇簾襯夢鏇襯鏇築糧製觸簾憲齋蓋鹽襯壓廠衊 (築襯窪鹹繭範獵淵築衊, 艱襯選網選窪糧憲觸鑰 ~ 觸憲選蓋鏇夢鹹齋網廠) 更多	-	2019-10-28
				PVP-I 0.6% (PVP-I 0.6%)	窪壓鏇衊製蓋壓積遞鹽(網積蓋觸鹽顧製艱簾衊) = 觸鹽構廠鬱壓糧壓鬱衊觸簾憲齋蓋鹽襯壓廠衊 (築襯窪鹹繭範獵淵築衊, 積網壓網淵蓋鹽衊艱廠 ~ 襯憲壓獵鹹選壓襯齋願) 更多