REGIONAL CENTER--HERPETIC EYE DISEASE STUDY, PHASE II

区域中心--疱疹性眼病研究，第二阶段

• 批准号: 3559964
• 负责人: BRUCE A BARRON
• 金额: $ 12.82万
• 依托单位: LSU HEALTH SCIENCES CENTER
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-08-01 至 1997-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559964
• 关键词: acyclovir; clinical trials; community; disease /disorder prevention /control; drug screening /evaluation; eye disorder chemotherapy; human subject; human therapy evaluation; iritis; keratitis; medical complication; ocular herpes; questionnaires; relapse /recurrence; stress; trauma

The Louisiana State University (LSU) Eye Center, a participant in the current Herpetic Eye Disease Study (HEDS), proposes to be a Regional Center for Phase II of the Herpetic Eye Disease Study. Phase II will consist of two randomized, double-masked clinical trials and a non-experimental study of recurrence factors of ocular herpetic disease. The first trial, Herpetic Eye Disease Study - Epithelial Keratitis Trial (HEDS-EKT), will compare oral acyclovir to placebo for the prevention or delay of subsequent stromal keratitis or iritis in patients with active herpetic epithelial keratitis. The second trial, Herpetic Eye Disease Study - Acyclovir Prevention Trial (HEDS-APT) will compare oral acyclovir to placebo for prolonging time to recurrence of herpetic eye disease in patients with an episode of any herpetic eye disease in the past year who have been free of disease and off all treatment for the past month. The Recurrence Factors Study will obtain data by questionnaire on stress, trauma, and other potential recurrence factors of herpetic disease for correlation with recurrence data from the two clinical trials. As a Regional Center, the LSU Eye Center will be responsible for entering patients in the two clinical trails, and treating and following them according to protocol; entering randomized patients into the Recurrence Factors Study; coordinating and overseeing the participation of eight additional Participating Sites in the EKT and APT trials; and participating in the governance of HEDS via participation on the Executive Committee.

路易斯安那州立大学（LSU）眼中中心，参与者 当前的疱疹眼病研究（HEDS）提议为区域中心 对于疱疹眼病研究的第二阶段。 第二阶段将包括 两项随机的双掩盖临床试验和一项非实验性研究 眼疱疹疾病的复发因素。 第一个试验，疱疹眼病研究 - 上皮性角膜炎试验 （HEDS-EKT），将比较口头阿西洛韦与安慰剂进行预防或 活跃患者的随后的基质角膜炎或肠炎延迟 疱疹上皮性角膜炎。 第二次试验，疱疹眼病 研究-Acyclovir预防试验（HEDS -APT）将比较口服Acyclovir 安慰剂延长时间以复发疱疹眼病 过去一年中有任何疱疹性眼病发作的患者 在过去一个月中，已经没有疾病和所有治疗方法。 这 复发因素研究将通过问卷调查获得有关压力的数据， 创伤和其他潜在复发因素的疱疹性疾病因素 与两个临床试验的复发数据相关。 作为区域中心，LSU眼中心将负责进入 两条临床踪迹中的患者，并治疗并遵循 根据协议；将随机患者进入复发 因素研究；协调和监督八个的参与 EKT和APT试验中的其他参与站点；并参与 在Heds的治理中，通过参加执行委员会。