HERPETIC EYE DISEASE STUDY-PHASE II

申请者，当前疱疹眼病的领头羊 研究(HEDS)，建议成为以下项目的牵头中心和区域中心 HEDS第二阶段。第二阶段将包括两个随机的、双掩蔽的 诱发因素的临床试验和非实验研究 眼部疱疹的复发。 HEDS小组现在建议评估口服阿昔洛韦对 预防疱疹间质性角膜炎和虹膜睫状体炎 抑制复发。一项新的HEDS方案将评估口服 阿昔洛韦治疗急性疱疹上皮性角膜炎 预防基质角膜炎和虹膜睫状体炎(疱疹眼病 研究-上皮性角膜炎试验：HEDS-EKT)。第二项协议将 口服阿昔洛韦预防复发的疗效评价 疱疹病毒性眼病的发作(疱疹眼病研究- 阿昔洛韦预防试验--HEDS-APT)。第三项关于生物和生物的研究 疱疹病毒性眼病复发的心理危险因素 (疱疹眼病-风险因素研究：HEDS RFS)将决定 在两项临床试验中，这些因素在患者中的重要性。 这些研究将利用基于社区的临床试验设计和 包括8个区域中心，每个中心有5到11个参与地点。 领导中心将为以下人员制定和实施培训计划 区域和参与中心，认证和监控区域 中心，作为执行中心，并参与整体 通过参与所有HEDS委员会对HEDS的治理。 作为区域中心，申请者将在两个地方录入患者 根据方案进行临床试验，并将进入随机患者 进入触发者研究。它将协调和监督 另有11个参与的本地地点参与演艺中心及 ECT试验。

The applicant, the Lead Center in the current Herpetic Eye Diseases Study (HEDS), proposes to be the Lead Center and a Regional Center for Phase II of HEDS. Phase II will consist of two randomized, double-masked clinical trials and a non-experimental study of trigger factors of recurrence of ocular herpetic diseases. The HEDS group now proposes to evaluate oral acyclovir for the prevention of herpetic stromal keratitis and iridocyclitis and the suppression of recurrences. One new HEDS protocol will evaluate oral acyclovir given during acute herpetic epithelial keratitis for preventing stromal keratitis and iridocyclitis (Herpetic Eye Disease Study - Epithelial Keratitis Trial: HEDS-EKT). A second protocol will evaluate the efficacy of oral acyclovir for preventing recurrent episodes of herpetic eye disease (Herpetic Eye Diseases Study - Acyclovir Prevention Trial - HEDS-APT). A third study of biological and psychological risk factors for recurrences of herpetic eye disease (Herpetic Eye Disease - Risk Factor Study: HEDS RFS) will determine the importance of these factors among patients in the two clinical trials. The studies will utilize a community-based clinical trial design and include eight regional centers with five to 11 participating sites each. The Lead Center will develop and carry out training programs for the Regional and Participating Centers, certify and monitor Regional Centers, act as the executive center, and participate in the overall governance of HEDS by participation in all HEDS committees. As a Regional Center, the applicant will enter patients in the two clinical trials according to protocol and will enter randomized patients into the triggers study. It will coordinate and oversee the participation of 11 additional participating local sites in the APT and EKT trials.