A Randomized Trial of Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measure of time to first recurrence
研究概览
简要总结
This is a prospective, randomized clinical trial looking to determine the role of prophylactic treatment with topical corticosteroids in preventing recurrences in patients with a history of infectious epithelial keratitis, stromal keratitis,endotheliitis, or iridocyclitis. Patients will be enrolled to one of two treatment arms: Control arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg daily or Study arm: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject capable of giving informed consent and if not, an acceptable surrogate capable of giving informed consent on behalf of the subject.
- •Diagnosed with a history of herpetic eye disease
- •Three or more episodes of HSV keratitis based on medical record documentation of episodes with infectious epithelial keratitis, immune stromal keratitis with or without epithelial ulceration, endothelitis, or iridocyclitis.
- •Prior history of HSV keratitis based on medical record documentation of episode of infectious epithelial keratitis, immune stromal keratitis with or without epithelial ulceration, endothelitis, or iridocyclitis and corneal scarring in the central 4mm zone.
排除标准
- •Persons who are pregnant or nursing or intend to become pregnant or nurse in the next one year.
- •Allergy to acyclovir, fluoromethalone, loteprednol, prednisolone acetate, prednisolone sodium phosphate, or any components of the formulations.
- •Persons who are incarcerated.
- •Unable to give informed consent or have an acceptable surrogate capable of giving informed consent on behalf of the subject.
- •Persons with systemic medical problems who do not agree to have continued medical follow-up.
- •History of topical corticosteroids to the eyelids or ocular surface of the involved eye within the prior 30 days prior to enrollment.
- •Patients with 3 or more episodes of uveitis in the past 12 months.
- •History of keratoplasy or keratorefractive surgery of the involved eye.
- •History of open or closed angle glaucoma or ocular hypertension on gtts.
- •History of systemic steroid use within the prior 30 days.
- •Unable to comply with the study protocol or in the opinion of the investigator would not be a candidate for participation.
- •Persons who are unable to instill gtts despite training/caregiver.
研究组 & 干预措施
Control
suppressive antiviral treatment
干预措施: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily (Drug)
Study Arm
oral acyclovir or oral valacyclovir
干预措施: oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops (Drug)
结局指标
主要结局
Measure of time to first recurrence
时间窗: 24 Months
Kaplan-Meier curves will be plotted by treatment arm (overall and by site) and 95% confidence intervals for the difference between the time to first recurrences will be estimated. Results will also be plotted by site to provide descriptive summaries of the results.
次要结局
未报告次要终点