Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in marginal reflex distance-2 (MRD2)
研究概览
简要总结
This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.
详细描述
The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.
排除标准
- •Patients receiving mono-amino-oxidase inhibitors.
- •Patients with history of hypertension, cardiac, or cerebrovascular disease.
- •Women with confirmed pregnancy.
研究组 & 干预措施
Patients
Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye. Objective measurements of ptosis will be taken before drug administration and at 1, 5, 30, 60 minutes after drug administration in order to analyze any change in ptosis.
干预措施: Apraclonidine Hcl 0.5% Oph Soln (Drug)
结局指标
主要结局
Change in marginal reflex distance-2 (MRD2)
时间窗: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in MRD2 measurements
Change in marginal reflex distance-1 (MRD1)
时间窗: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in MRD1 measurements
Change in levator function (LF)
时间窗: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in LF measurements
Change in palpebral fissure height (PF)
时间窗: Before administration, at 1, 5, 30, and 60 minutes after administration
Change in PF measurements
次要结局
未报告次要终点
研究者
Johnny Salameh
Associate Professor, Department of Neurology
American University of Beirut Medical Center