HERPES EYE DISEASE

疱疹性眼病

• 批准号: 2163381
• 负责人: ELISABETH J COHEN
• 金额: $ 10.04万
• 依托单位: WILLS EYE HEALTH SYSTEM
• 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/2163381
• 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 applicant, 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 nonexperimental study of triggers of recurrence of ocular herpetic disease. The first trial, HEDS-EKT, will compare acyclovir to placebo for the prevention or delay of subsequent keratitis or iritis in patients with active herpetic epithelial keratitis. The second, HEDS-APT, will compare 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 and who have been free of disease and off all treatment for the past month. The triggers study will obtain data by questionnaire on stress, stress, trauma, and other potential triggers of recurrence or herpetic disease for correlation with recurrence data from the two clinical trials. As a Regional Center, the applicant will be responsible for entering patients in the two clinical trials, and treating and following them according to protocol; entering consenting randomized patients into the triggers study; coordinating and overseeing the participating of 9 additional participating local sites in the APT and EKT trials; and participating in the governance of HEDS via participation on the Executive Committee.

申请人，当前疱疹眼病研究的参与者 （HEDS），提议为疱疹眼的第二阶段中心 疾病研究。 第二阶段将由两个随机，双掩蔽组成 临床试验和对复发触发因素的非实验性研究 眼疱疹疾病。 第一次试验Heds-Ekt将将Acyclovir与安慰剂进行比较 患者的预防或延迟随后的角膜炎或肠炎 活跃的疱疹性上皮角膜炎。 第二个，heds-apt将比较 阿西克罗维尔（Acyclovir）到安慰剂，延长了疱疹眼的复发 过去患有任何疱疹眼病的患者的疾病 一年，没有疾病，过去的所有治疗 月。 触发器的研究将通过问卷调查获得有关压力的数据， 压力，创伤和其他复发或疱疹的潜在触发器 与两个临床试验的复发数据相关的疾病。 作为区域中心，申请人将负责进入 在两个临床试验中的患者，并治疗并遵循 根据协议；将同意的随机患者纳入 触发器研究；协调和监督9的参与 APT和EKT试验中的其他参与本地站点；和 通过参与高管参加HEDS的治理 委员会。