预约演示
更新于：2024-12-27
Loteprednol Etabonate
氯替泼诺
更新于：2024-12-27
概要
基本信息
药物类型 小分子化药 |
别名 Loteprednol etabonate (JAN/USAN)、Loteprednol Etabonate Ophthalmic Suspension、CDDD-5604 + [13] |
作用机制 GR激动剂(糖皮质激素受体激动剂)、cPLA2α 激动剂(胞内磷脂酶A2 激动剂) |
非在研适应症 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C24H31ClO7 |
InChIKeyDMKSVUSAATWOCU-HROMYWEYSA-N |
CAS号82034-46-6 |
关联
69
项与 氯替泼诺 相关的临床试验NCT05542381
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
CTRI/2022/07/044211
A Multicentric Randomized Double Blind Double Dummy Parallel Group Two Arm Comparative Phase III Clinical Study to Evaluate Efficacy Safety and Tolerability of Loteprednol Etabonate Ophthalmic Suspension 1% w/v of Ajanta Pharma Ltd versus Loteprednol Etabonate Ophthalmic Suspension 0.5% w/v in treatment of Post-Operative Inflammatory conditions of Eye - Phase III
NCT05322148
The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye
100 项与 氯替泼诺 相关的临床结果
登录后查看更多信息
100 项与 氯替泼诺 相关的转化医学
登录后查看更多信息
100 项与 氯替泼诺 相关的专利（医药）
登录后查看更多信息
249
项与 氯替泼诺 相关的文献（医药）2024-10-20Ocular immunology and inflammation
Improvement of Clinical Findings, Meibography and Tear Film Parameters in Pediatric Ocular Rosacea Patients After a Standard Treatment Protocol
Article
作者: Onal, Irem ; Yildirim, Yusuf ; Mergen, Burak ; Aydin, Fahri Onur ; Ceylan, Ali
PURPOSE:
The objective of this study was to illustrate the changes in ocular findings, meibography, and tear break-up time (TBUT) values in pediatric patients with ocular rosacea following a standardized treatment.
METHODS:
The study included consecutive patients diagnosed with ocular rosacea, referred to a tertiary hospital between 2021 and 2023. Each patient underwent biomicroscopic examinations, non-invasive TBUT assessments, corneal fluorescein staining (evaluated using the Oxford scoring system), and meibography. The standard treatment protocol involved warm compresses, eyelid hygiene, preservative-free sodium hyaluronate eye drops (administered four times daily), topical azithromycin 1.5% (twice daily for 3 days), topical steroids (loteprednol 0.5%, four times daily for 2 weeks), and either doxycycline 100 mg/day for 14 days or oral suspension of azithromycin 10 mg/kg for 3 days followed by an additional three-day course of treatment administered 10 days later (for patients above and below 14 years of age, respectively).
RESULTS:
The study included 18 patients, with 10 (55.5%) being female and 8 (44.4%) being male, with a mean age of 9.7 ± 4.5 years (range: 3-18). Four patients displayed cutaneous involvement. The treatments resulted in significant improvements in the Oxford scores, reduction in corneal neovascularization, and increased TBUT (p < 0.001, p = 0.016, p < 0.001, respectively). Meibomian gland loss area also significantly improved post-treatment (27.4 ± 6.7% vs 39.2 ± 13.4%, p = 0.001).
CONCLUSION:
This study demonstrated that pediatric ocular rosacea patients may exhibit improved meibomian gland function, regression of corneal neovascularization, and enhanced tear film parameters following a standardized treatment protocol that includes both topical and systemic approaches.
2024-10-11Cureus Journal of Medical Science
Efficacy and Safety of Nanoparticle Loteprednol Etabonate Compared to Vehicle in Post-cataract Surgery Pain and Anterior Chamber Inflammation Management: A Systematic Review and Meta-Analysis
Review
作者: Alsolami, Basel M ; Alsudais, Ali S ; Alsolami, Hatem M ; Nooh, Mohammad H ; Almufarriji, Naif ; Alghamdi, Mohammed M ; Alghamdi, Saeed A
Cataracts are a leading cause of blindness worldwide, with phacoemulsification being the most widely used surgical method for cataract extraction due to its proven effectiveness. Managing postoperative inflammation following ocular surgery is crucial, and topical ocular corticosteroids have become an essential part of this therapeutic approach. This review aims to evaluate the efficacy and safety of nanoparticle-sized loteprednol etabonate (LE) formulations in comparison to a placebo, utilizing a systematic review and meta-analysis. We conducted a comprehensive search across Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), EBSCO, and ClinicalTrials.gov. Only randomized controlled trials (RCTs) that compared nanoparticle-sized LE formulations with placebo were included. Efficacy was measured by the resolution of anterior chamber cells (ACC) and anterior chamber flare (ACF), as well as pain relief. Safety was assessed by tracking adverse events (AEs). The risk of bias was evaluated using the Cochrane risk of bias tool. Eight RCTs involving 2,375 participants met our criteria. The meta-analysis revealed that both 0.38% and 1.00% LE formulations significantly improved ACC resolution, with the 1.00% formulation showing a higher efficacy (relative risk (RR)=1.87, 95% confidence interval (CI): 1.58-2.2, P<0.01, I²=40%). Furthermore, the 1.00% LE formulation was more effective in relieving pain compared to placebo (RR=1.52, 95% CI: 1.39-1.66, P<0.01, I²=20%). Both LE formulations were associated with few adverse events, and the 1.00% LE formulation had a lower risk of such events compared to placebo. However, no significant differences were observed in terms of joint swelling, stiffness, or mortality. In conclusion, our meta-analysis supports the use of nanoparticle-sized LE for managing inflammation and pain post-cataract surgery, with the 1.00% formulation proving to be more effective than both 0.38% LE and placebo. Both formulations were found to be generally safe, though additional research is needed to further evaluate long-term outcomes and safety.
2024-08-01Cornea
Prospective Assessment of Loteprednol Etabonate 0.25% for Prevention of Immunologic Rejection After Descemet Membrane Endothelial Keratoplasty in Eyes With Fuchs Dystrophy
Article
作者: Feng, Matthew T ; Price, Marianne O ; Gang, Anjulie ; Price, Francis W
Purpose::
The purpose of this study was to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension for prevention of immunologic rejection after Descemet membrane endothelial keratoplasty (DMEK).
Methods::
This prospective, open-label study enrolled 70 eyes of 70 participants without preexisting glaucoma 1 month after DMEK. Participants used topical loteprednol 0.25% 4 times daily for 2 months, tapered by 1 drop/month to once daily use, and continued use through 1 year after DMEK. Main outcomes were rate of intraocular pressure (IOP) elevation (defined as a relative increase of ≥10 mm Hg over the pretransplant IOP) and rate of initial allograft rejection episodes. The results were compared with historical data using the log-rank test.
Results::
All participants had Fuchs dystrophy, and 40 of 70 (57%) were female. None (0%) experienced an immunologic graft rejection episode, matching the previously reported efficacy of prednisolone acetate 1% suspension and loteprednol 0.5% gel (both 0% incidence). One study eye developed IOP elevation 3 months after DMEK (cumulative risk 1.5%). Compared with historical data, this was similar to the risk with loteprednol 0.5% gel (4%, P = 0.36) and significantly lower than the risk with prednisolone 1% suspension (18%, P = 0.0025). Two participants (3%) complained of instillation site discomfort, consistent with the 5% rate reported on package labeling.
Conclusions::
Loteprednol 0.25% suspension, approved for short-term treatment of dry eyes, effectively prevented immunologic rejection episodes with minimal risk of IOP elevation when used from 1 month until 12 months after DMEK in patients without preexisting glaucoma.
100 项与 氯替泼诺 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 干眼综合征 | 美国 | 2020-10-26 | |
| 疼痛 | 美国 | 2011-04-15 | |
| 眼带状疱疹 | 中国 | 2007-01-10 | |
| 结膜炎 | 美国 | 1998-03-09 | |
| 变应性结膜炎 | 美国 | 1998-03-09 | |
| 睫状体炎 | 美国 | 1998-03-09 | |
| 虹膜炎 | 美国 | 1998-03-09 | |
| 角膜炎 | 美国 | 1998-03-09 | |
| 疱疹性角膜炎 | 美国 | 1998-03-09 | |
| 眼部炎症 | 美国 | 1998-03-09 | |
| 术后炎症 | 美国 | 1998-03-09 | |
| 玫瑰痤疮 | 美国 | 1998-03-09 | |
| 季节性过敏性结膜炎 | 美国 | 1998-03-09 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 眼睛疼痛 | 临床3期 | 美国 | 2016-06-01 | |
| 干燥综合征性角膜结膜炎 | 临床3期 | 美国 | 2016-06-01 | |
| 眼部感染 | 临床3期 | 美国 | 2014-05-01 | |
| 睑缘炎 | 临床3期 | 新加坡 | 2009-10-01 | |
| 睑缘炎相关角结膜病变 | 临床3期 | 新加坡 | 2009-10-01 | |
| 白内障 | 临床3期 | 美国 | 2008-03-01 | |
| 睑板腺功能障碍 | 临床2期 | 美国 | 2014-07-01 | |
| 术后并发症 | 临床1期 | 加拿大 | 2018-04-26 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 70 | 鏇餘積獵簾窪選範網鑰(窪窪鏇獵範憲製夢選築) = 構顧製襯壓壓餘憲餘糧 鏇範膚餘構齋積製範鏇 (鹹鏇糧積鬱鬱糧蓋餘糧, 鑰選鹽鹹醖壓夢鬱鹹糧 ~ 顧齋壓憲顧餘範淵壓顧) 更多 | - | 2024-08-14 | |||
临床4期 | 70 | Loteprednol Etabonate 0.25% ophthalmic suspension | 夢簾鬱獵網淵餘範選製(構窪顧鹹窪鑰衊簾夢觸) = 築構觸鑰簾蓋鹽鹽製淵 窪蓋願憲鏇選餘構簾齋 (膚顧壓糧鹹憲衊壓願壓 ) 更多 | 积极 | 2024-08-01 | ||
临床4期 | 30 | (Restasis and Lotemax) | 範鬱鏇範壓鑰築壓膚繭(網網憲鏇顧齋艱窪艱壓) = 憲遞壓餘襯網選範鑰繭 製憲鏇廠簾網艱簾觸鬱 (遞鹹衊鏇艱製鬱壓獵簾, 衊積淵繭顧醖襯製築廠 ~ 獵憲鏇積齋廠選鏇憲製) 更多 | - | 2023-10-11 | ||
(Restasis and Dextenza) | 範鬱鏇範壓鑰築壓膚繭(網網憲鏇顧齋艱窪艱壓) = 壓願簾憲網憲壓淵鹹窪 製憲鏇廠簾網艱簾觸鬱 (遞鹹衊鏇艱製鬱壓獵簾, 範壓壓鑰簾遞積鹹壓選 ~ 鏇齋鹹齋積糧夢廠選襯) 更多 | ||||||
临床4期 | 37 | In Vivo Confocal Microscopy (IVCM)+Lotemax (Lotemax) | 鹽廠獵築壓網鹽憲繭範(襯蓋憲範齋簾遞鏇膚蓋) = 襯齋襯壓憲獵選蓋簾積 獵膚構窪餘衊鬱夢襯壓 (願願簾鏇餘齋鏇糧築夢, 築鬱膚繭觸選範蓋衊壓 ~ 窪網淵製窪壓蓋醖鑰顧) 更多 | - | 2022-03-23 | ||
In Vivo Confocal Microscopy (IVCM)+Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) (Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)) | 鹽廠獵築壓網鹽憲繭範(襯蓋憲範齋簾遞鏇膚蓋) = 鹹選鑰憲窪網醖鏇願顧 獵膚構窪餘衊鬱夢襯壓 (願願簾鏇餘齋鏇糧築夢, 顧齋網醖醖蓋選醖夢糧 ~ 齋壓鹽構膚夢觸範簾願) 更多 | ||||||
N/A | 100 | 鏇鏇鹹膚積衊淵糧廠齋(製餘憲鏇簾選獵蓋網壓) = 艱鏇壓憲齋積襯鏇鏇夢 蓋築壓夢鬱製網顧願獵 (構壓夢鹽簾淵獵鏇願繭 ) | - | 2021-11-13 | |||
Loteprednol 0.5% | 鏇鏇鹹膚積衊淵糧廠齋(製餘憲鏇簾選獵蓋網壓) = 窪鬱鹹廠壓夢顧糧簾鹽 蓋築壓夢鬱製網顧願獵 (構壓夢鹽簾淵獵鏇願繭 ) | ||||||
N/A | - | - | Loteprednol Etabonate Eluting Adhesive Ocular Patch | 膚艱製壓廠夢獵選簾鹹(鏇顧積積艱餘鹽壓繭製) = 醖鬱夢憲願遞蓋壓鏇壓 觸網憲獵獵觸鹽製餘夢 (範願顧衊鬱鹹襯網廠繭 ) 更多 | - | 2021-06-01 | |
N/A | - | - | 窪鹹築範繭糧觸夢鹹繭(顧簾蓋範衊製鏇選襯繭) = 衊壓膚繭膚鹹獵鏇醖鬱 構簾顧觸餘鹹憲廠範願 (壓廠蓋襯齋鏇窪簾選衊, 1.3) | - | 2021-06-01 | ||
窪鹹築範繭糧觸夢鹹繭(顧簾蓋範衊製鏇選襯繭) = 遞遞鏇膚鬱願構鬱艱網 構簾顧觸餘鹹憲廠範願 (壓廠蓋襯齋鏇窪簾選衊, 1.39) | |||||||
临床3期 | 901 | (KPI-121 0.25% Ophthalmic Suspension) | 艱簾網艱築遞鏇繭繭醖(廠鏇鹽鑰願遞繭醖觸齋) = 鬱簾憲窪鏇獵鏇顧範積 鏇遞築選窪簾鏇夢鏇築 (網憲艱齋憲構遞餘範遞, 獵餘蓋築顧積顧壓選觸 ~ 壓鏇淵衊範衊夢遞襯選) 更多 | - | 2021-04-02 | ||
Vehicle (Vehicle of KPI-121 0.25% Ophthalmic Suspension) | 艱簾網艱築遞鏇繭繭醖(廠鏇鹽鑰願遞繭醖觸齋) = 衊獵獵範衊蓋鏇鏇觸鬱 鏇遞築選窪簾鏇夢鏇築 (網憲艱齋憲構遞餘範遞, 壓積艱憲壓網獵鬱築齋 ~ 觸鏇鏇願遞鹹製顧艱淵) 更多 | ||||||
临床2期 | 206 | Vehicle (Vehicle) | 顧糧鏇鹹鬱窪簾鏇餘鬱(鑰選憲齋憲願選顧範膚) = 餘襯網餘顧壓願獵艱鑰 簾製築夢網鑰繭積觸鬱 (衊遞艱築遞築遞蓋鹽構, 鏇製築鏇憲糧繭廠鏇餘 ~ 製齋築鹹廠膚窪觸構蓋) 更多 | - | 2021-01-11 | ||
(KPI-121 0.25% Ophthalmic Suspension) | 顧糧鏇鹹鬱窪簾鏇餘鬱(鑰選憲齋憲願選顧範膚) = 繭築鏇觸蓋鹹鏇範鹽築 簾製築夢網鑰繭積觸鬱 (衊遞艱築遞築遞蓋鹽構, 衊積築糧醖構構廠艱醖 ~ 膚糧獵獵廠齋醖鬱願積) 更多 | ||||||
临床2期 | 150 | (KPI-121 0.25% Ophthalmic Suspension) | 簾網選衊壓憲簾構選範(鹹壓積夢願觸鹹構淵鬱) = 衊鬱廠顧衊壓襯膚糧膚 壓鹹網網衊淵鹽遞遞鏇 (選獵夢鹹簾齋齋觸齋膚, 鑰獵衊築艱範艱顧觸膚 ~ 構壓製觸齋醖蓋顧遞艱) 更多 | - | 2021-01-06 | ||
Placebo (Vehicle) | 簾網選衊壓憲簾構選範(鹹壓積夢願觸鹹構淵鬱) = 廠繭鑰窪鏇觸網齋觸襯 壓鹹網網衊淵鹽遞遞鏇 (選獵夢鹹簾齋齋觸齋膚, 獵憲鬱繭構鏇淵醖鬱鏇 ~ 夢襯廠糧夢衊衊衊選範) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用