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：
10655408
负责人：
Gui-shuang Ying
金额：
$ 84.57万
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 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10655408
关键词：
Adoption Adverse event Affect Anti-Inflammatory Agents Area Blindness Cataract Extraction Certification Chairperson Chronic Clinical Clinical Trials Collaborations Complication Data Data Collection Data Management Resources Databases Defect Drops Eligibility Determination Enrollment Ensure Entropion Ethiopia Eye Eyedrops Eyelid structure Fluorometholone Grant Granuloma Hair Removal Incidence Inflammation Lead Leadership Location Logistic Regressions Maintenance Masks Measures Medical Modeling Monitor Online Systems Operative Surgical Procedures Outcome Pathogenicity Patient Outcomes Assessments Patients Penetration Performance Persons Pharmaceutical Preparations Pharmacy facility Placebos Postoperative Period Preparation Process Publications Randomized Recommendation Recording of previous events Recurrence Repeat Surgery Reporting Risk Role Safety Schedule Secure Statistical Data Interpretation Surgeon System 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.

Trachoma，世界各地失明的主要感染原因。气管曲菌病（TT），A 慢性沙眼引起的塞卡酸化的并发症是导致的关键机制沙眼瘤的失明。目前，缓解刻板病的手术是全球关键的程序化防止沙眼失明的策略。不幸的是，复发率不高（约20-30％）TT手术后。由于手术本身和/或气管性引起的炎症致病过程可能有助于TT复发。我们的初步试验发现炎症性荧光甲酮0.1％眼架与一年TT的风险降低〜1/3有关复发性比安慰剂组，氟乙醇酮0.1％具有最小的副作用。作为TT手术（火焰）试验的辅助药物疗法的氟乙醇酮是双重的掩盖的安慰剂对照的随机临床试验，以评估疗效，安全性和成本荧光甲酮0.1％眼药的有效性作为TT手术的辅助疗法埃塞俄比亚。数据中心（DC）将与研究主席办公室密切合作埃塞俄比亚协调中心（FCC），执行委员会（EC）和数据安全监测委员会（DSMC）确保审判的成功。 DC在此试验中的作用是提供有关设计，实施和维护高的领导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，表明氟乙醇酮是否0.1％应该建议将广泛采用的编程有用的策略作为一种有用的策略沙眼失明缓解计划。证明有效性，安全性及其成本效益氟乙醇酮0.1％EyeDrops将为改善TT和TT处理的机会减少全球TT的视觉障碍和失明。