A Prospective, Double-masked, Placebo Controlled Comparison of Topical 0.15% Gancyclovir Gel (Zirgan) Versus 0.3% Hypromellose Gel (Genteal Gel; Placebo) for the Treatment of Herpes Zoster Keratitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Corneal Ulcer Healing
研究概览
简要总结
The purpose of this study is to evaluate the efficiency of topical gancyclovir 0.15% in the treatment of herpes zoster keratitis. Half the patients will receive the study drug while the other half of the patients will receive the placebo
详细描述
Patients with herpes zoster keratitis will be enrolled in the study. All patients will receive oral anti-viral medication as a standard-of-care therapy. The patients will be randomized into two groups and given either the study drug or the placebo at the time of enrollment. The patients will come for weekly visits during which slit lamp photograph of the dendrite will be taken. At week 2, if the dendrite has not healed the drug will by unmasked and rescue therapy will be given. the patients will be examined at week 1, 2, and 3 or until resolution occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18 and above
- •have not been on gancyclovir gel or any other form of topical antiviral therapy for the past month
- •able and willing to attend subsequent follow-up visits
排除标准
- •Associated retinitis
- •patients who are allergic to gancyclovir
- •patients who will require systemic or intra-vitreal gancyclovir therapy
- •patients who are pregnant or breastfeeding
研究组 & 干预措施
Gancyclovir gel
0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.
干预措施: gancyclovir gel (Drug)
hypromellose gel
0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.
干预措施: Hypromellose gel (Drug)
结局指标
主要结局
Corneal Ulcer Healing
时间窗: 2 weeks
Based on weekly slitlamp photographs
次要结局
未报告次要终点
研究者
Robert Feder
Professor of Ophthalmology
Northwestern University