Fluoromethelone as Adjunctive Medical Therapy for TT Surgery (FLAME) Trial

氟米龙作为 TT 手术辅助药物治疗 (FLAME) 试验

基本信息

批准号：
10204000
负责人：
Gui-shuang Ying
金额：
$ 37.03万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10204000
关键词：
Adoption Adverse event Affect Anti-Inflammatory Agents Area Blindness Cataract Extraction Certification Chairperson Chronic Clinical Clinical Trials Complication Data Data Collection Data Management Resources Databases Defect Drops Enrollment Ensure Entropion Ethiopia Eye Eyedrops Eyelid structure Fluorometholone Grant Granuloma Hair Removal Incidence Inflammation Investigation Lead Leadership Location Logistic Regressions Maintenance Masks Measures Medical Modeling Monitor Online Systems Operative Surgical Procedures Outcome Pathogenicity Patient Outcomes Assessments Patients Penetration Performance Pharmaceutical Preparations Pharmacy facility Placebos Postoperative Period Preparation Process Publications Randomized Recording of previous events Recurrence Repeat Surgery Reporting Risk Role Safety Schedule Secure Statistical Data Interpretation Surgeon System Time Touch sensation Trachoma Training Visit Visual Acuity Visual impairment clinical outcome measures compliance behavior cost effectiveness data centers data management design efficacy evaluation improved meetings mobile application notch protein ocular surface pain score placebo group prevent primary outcome programs quality assurance randomized placebo-controlled clinical trial safety outcomes secondary analysis secondary outcome side effect success trial design

项目摘要

Trachoma, the leading infectious cause of blindness worldwide. Trachomatous trichiasis (TT), a complication of the chronic trachoma-induced cicatrization, is a key mechanism leading to blindness from trachoma. Currently, surgery to relieve trichiasis is a key global programmatic strategy to prevent trachoma blindness. Unfortunately, an undesirably high recurrence rate (about 20-30%) following TT surgery. Inflammation due to surgery itself and/or the trachomatous pathogenic process likely contributes to TT recurrence. Our preliminary trial found that anti- inflammatory fluorometholone 0.1% eyedrops was associated with ~1/3 lower risk of one-year TT recurrence than the placebo group, and fluorometholone 0.1% had minimal side effects. The FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a double- masked placebo-controlled randomized clinical trial to evaluate the efficacy, safety and cost- effectiveness of fluorometholone 0.1% eyedrops as an adjunctive therapy for TT surgery in Ethiopia. The Data Center (DC) will collaborate closely with the Study Chairman's Office, the Field Coordinating Center (FCC) in Ethiopia, the Executive Committee (EC), and the Data Safety Monitoring Committee (DSMC) to ensure the success of the trial. The DC's role for this trial is to provide leadership and expertise on design of trials, implementation and maintenance of high quality data management system, statistical analysis and publication of trial findings. Results of this trial will provide Level 1 evidence as to whether fluorometholone 0.1% eyedrops should be recommended as a programmatically useful strategy for widespread adoption into trachoma blindness alleviation programs. Proof of the efficacy, safety and its cost-effectiveness of fluorometholone 0.1% eyedrops would provide an opportunity to improve the treatment of TT and reduce the visual impairment and the blindness from TT globally.

沙眼是全世界导致失明的主要传染性疾病。沙眼倒睫（TT）慢性沙眼引起的疤痕的并发症，是导致沙眼导致失明。目前，缓解倒睫的手术是全球一项重要的计划预防沙眼失明的策略。不幸的是，复发率过高 (约 20-30%) TT 手术后。由于手术本身和/或沙眼引起的炎症致病过程可能导致 TT 复发。我们的初步试验发现，反炎性氟米龙 0.1% 滴眼液与一年 TT 风险降低约 1/3 相关复发率高于安慰剂组，且 0.1% 氟米龙的副作用最小。氟米龙作为 TT 手术辅助药物治疗 (FLAME) 试验是一项双掩蔽安慰剂对照随机临床试验，评估疗效、安全性和成本 0.1%氟米龙滴眼液作为 TT 手术辅助治疗的有效性埃塞俄比亚。数据中心（DC）将与研究主席办公室、现场埃塞俄比亚协调中心 (FCC)、执行委员会 (EC) 和数据安全监督委员会（DSMC）确保试验的成功。 DC 在本次试验中的作用是提供试验设计、实施和维护高水平的领导力和专业知识质量数据管理系统、统计分析和试验结果的发布。该试验的结果将提供 1 级证据证明 0.1% 氟米龙滴眼液是否有效应被推荐为一种在程序上有用的策略，以供广泛采用沙眼失明缓解计划。有效性、安全性及其成本效益的证明 0.1% 氟米龙滴眼液将为改善 TT 的治疗提供机会在全球范围内减少 TT 造成的视力障碍和失明。