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: 3559963
• 负责人: BRUCE A BARRON
• 金额: $ 12.21万
• 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/3559963
• 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) 眼科中心，参与 当前的疱疹性眼病研究（HEDS），提议成为一个区域中心 用于疱疹性眼病研究的第二阶段。 第二阶段将包括 两项随机、双盲临床试验和一项非实验研究 眼部疱疹病复发因素的研究. 第一项试验，疱疹性眼病研究——上皮性角膜炎试验 (HEDS-EKT)，将比较口服阿昔洛韦与安慰剂的预防或 活动性角膜炎或虹膜炎患者的后续基质性角膜炎或虹膜炎的延迟 疱疹性上皮性角膜炎。 第二次试验，疱疹性眼病 研究 - 阿昔洛韦预防试验 (HEDS-APT) 将比较口服阿昔洛韦 安慰剂可延长疱疹性眼病复发的时间 过去一年内曾患过任何疱疹性眼病的患者 过去一个月没有任何疾病并且停止了所有治疗。 这 复发因素研究将通过压力问卷获得数据， 外伤和其他潜在的疱疹疾病复发因素 与两项临床试验的复发数据的相关性。 作为区域中心，LSU 眼科中心将负责进入 两项临床试验中的患者、治疗和随访 根据协议；将随机患者纳入复发组 因素研究；协调和监督八个国家的参与 EKT 和 APT 试验的其他参与地点；并参与 通过参与执行委员会参与 HEDS 的治理。