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

• 批准号: 10018929
• 负责人: Gui-shuang Ying
• 金额: $ 37.31万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 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/10018929
• 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; Outcome Measure; 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; compliance behavior; cost effectiveness; data centers; data management; design; 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

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.

沙眼是世界范围内导致失明的主要传染病。沙眼性倒睫（TT），a 慢性沙眼诱导的瘢痕化的并发症，是导致 沙眼导致失明目前，手术缓解倒睫是一个关键的全球方案， 预防沙眼致盲战略。不幸的是，不期望的高复发率 （约20-30%）。手术本身和/或沙眼引起的炎症 致病过程可能有助于TT复发。我们的初步试验发现，反- 0.1%炎性氟米龙滴眼液与1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手术的辅助药物治疗（FLAME）试验是一项双重试验， 盲态安慰剂对照随机临床试验，以评估疗效、安全性和成本- 0.1%氟米龙滴眼液在TT手术中的应用 埃塞俄比亚. 数据中心（DC）将与研究主席办公室、 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），以确保试验的成功。检察官在这次审判中的角色是 在试验设计、实施和维护高质量的 质量数据管理系统、统计分析和发表试验结果。 本试验的结果将提供1级证据，以证明0.1%氟米龙滴眼液 应该推荐作为一种在编程上有用的策略， 减少沙眼致盲项目。有效性、安全性和成本效益的证明 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。