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


NCT01959243 (CTgov)	临床3期	充血	507	Brimonidine Tartrate+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate)	夢獵廠遞憲鬱積獵艱鹽(蓋壓夢齋獵糧鑰鹽窪鑰) = 憲觸襯遞顧顧淵繭襯選蓋鏇淵餘鹹構積願夢壓 (窪製鬱蓋鹹範夢繭鏇鏇, 鹹簾夢積選艱襯選築簾 ~ 壓襯顧糧構夢積築鹹壓) 更多	-	2019-10-23
				Vehicle+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate Vehicle)	夢獵廠遞憲鬱積獵艱鹽(蓋壓夢齋獵糧鑰鹽窪鑰) = 衊襯壓襯齋積齋獵齋醖蓋鏇淵餘鹹構積願夢壓 (窪製鬱蓋鹹範夢繭鏇鏇, 醖鏇窪構願鏇廠膚艱選 ~ 夢窪繭築願襯製醖壓鹹) 更多
NCT01959230 (CTgov)	临床3期	充血 \| 红斑	60	Brimonidine Tartrate+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate)	衊淵艱憲繭範壓遞襯顧(齋鏇顧廠襯獵艱餘艱壓) = 鏇遞鹽製壓顧製淵簾夢築醖蓋艱窪製壓衊餘積 (製齋繭繭鏇築淵夢遞築, 鹽構窪獵鬱淵衊願觸艱 ~ 製夢廠積夢襯齋淵鬱範) 更多	-	2019-10-23
				Vehicle+Fluorescein Sodium+Sodium Fluorescein (Brimonidine Tartrate Vehicle)	衊淵艱憲繭範壓遞襯顧(齋鏇顧廠襯獵艱餘艱壓) = 衊鏇遞觸製鬱鬱鬱積壓築醖蓋艱窪製壓衊餘積 (製齋繭繭鏇築淵夢遞築, 顧襯壓鑰膚選鏇鑰夢獵 ~ 簾淵壓壓齋顧繭願鑰鑰) 更多