A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Pediatric, Adult, and Geriatric Subjects

To compare the safety and tolerability of brimonidine tartrate ophthalmic solution 0.025% versus its vehicle in a population of pediatric, adult, and geriatric participants. At least 51% of participants will be 40 years of age or older.

开始日期2014-02-22

申办/合作机构

Bausch & Lomb, Inc.

[+1]

NCT01959230 / Completed临床3期

A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in a Population of Adult and Geriatric Subjects With Ocular Redness

To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.

开始日期2013-11-07

申办/合作机构

Bausch & Lomb, Inc.

[+1]

100 项与盐酸奥布卡因/荧光素钠相关的临床结果

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100 项与盐酸奥布卡因/荧光素钠相关的转化医学

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100 项与盐酸奥布卡因/荧光素钠相关的专利（医药）

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项与盐酸奥布卡因/荧光素钠相关的文献（医药）

1994-05-01·American Journal of Ophthalmology2区 · 医学

Potential Bacterial Contamination of Eyedrops Used for Tonometry

2区 · 医学

Article

作者: Rebecca Palmberg ; Darlene Miller ; Douglas R. Anderson ; William J. Feuer ; Yanet Suarez Gutierrez

We compared the potential for bacterial contamination of a proparacaine hydrochloride solution preserved with benzalkonium chloride, which is used with fluorescein paper for tonometry, to that of a fluorescein-benoxinate hydrochloride combination solution preserved with chlorobutanol. We contaminated bottles of each solution with Pseudomonas aeruginosa or Staphylococcus aureus (10(7) organisms per milliliter of eyedrop solution). From the fluorescein-benoxinate hydrochloride solution, Staphylococcus organisms were cultured in declining numbers over time, with a half-life of nine seconds, and no Staphylococcus organisms were recovered after five minutes. Pseudomonas organisms disappeared from this solution within 15 seconds. Neither species was viable after 15 seconds in the proparacaine hydrochloride solution. Additionally, we cultured 12 bottles of fluorescein-benoxinate hydrochloride and 15 bottles of proparacaine hydrochloride that had been in use in the clinic for one month. No organisms were recovered from a drop dispensed from any bottle or from the tips, caps, rims, or solution from within any bottle, except that five colonies of Staphylococcus grew from the external rim of one bottle. We conclude that both solutions sterilize themselves rapidly and effectively. Either may be used safely for tonometry.

100 项与盐酸奥布卡因/荧光素钠相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
麻醉	美国	Bausch + Lomb Ireland Ltd.	2020-03-09
眼科外科手术	美国	Altaire Pharmaceuticals, Inc.	2017-12-14

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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


NCT01959230 (CTgov)	临床3期	充血 \| 红斑	60	Brimonidine Tartrate+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate)	醖蓋憲積製壓淵窪餘窪(築鹹鹹網鏇廠鹹齋鹽淵) = 齋醖襯鏇鹽憲鏇鏇衊窪範窪鏇齋鹽鹽鑰齋鏇窪 (壓蓋糧夢糧蓋憲襯夢壓, 觸範簾繭蓋蓋蓋範夢糧 ~ 鏇獵糧壓願衊築鏇鑰夢) 更多	-	2019-10-23
				Vehicle+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate Vehicle)	醖蓋憲積製壓淵窪餘窪(築鹹鹹網鏇廠鹹齋鹽淵) = 選遞蓋壓憲網壓範窪觸範窪鏇齋鹽鹽鑰齋鏇窪 (壓蓋糧夢糧蓋憲襯夢壓, 夢憲夢壓廠憲願餘積齋 ~ 顧積顧餘繭窪觸鑰壓淵) 更多
NCT01959243 (CTgov)	临床3期	充血	507	Brimonidine Tartrate+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate)	窪餘選廠網窪齋醖範製(餘餘繭積膚淵顧窪窪網) = 觸膚鹹膚鑰蓋壓顧鏇鬱顧築網鑰淵壓觸糧選廠 (顧繭鹽鑰窪顧簾鏇網獵, 憲顧餘餘築範淵壓觸襯 ~ 壓齋膚遞製齋遞襯鹹憲) 更多	-	2019-10-23
				Vehicle+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate Vehicle)	窪餘選廠網窪齋醖範製(餘餘繭積膚淵顧窪窪網) = 簾範鑰壓廠願餘窪鹽顧顧築網鑰淵壓觸糧選廠 (顧繭鹽鑰窪顧簾鏇網獵, 夢衊製繭遞鬱願窪鏇簾 ~ 廠餘顧顧願築鬱顧繭醖) 更多