Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- alpha-2B receptor genotyping
研究概览
简要总结
Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma. Although adequate IOP reduction is achieved in many patients there is a considerable degree of variability in IOP reduction among subjects. The reason for this interindividual variability is not entirely clear. Obviously differences in pharmacokinetic properties due to variable penetration of the drug through the cornea may be responsible. Alternatively, polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering efficacy of topical brimonidine. This hypothesis is tested in the present study. Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally important, particularly a polymorphism of the alpha-2B receptor, which has a high allele frequency in caucasians.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged between 19 and 35 years, nonsmokers
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •IOP between 12 and 16 mmHg
- •Normal ophthalmic findings, ametropia < 3 Dpt.
- •Results of alpha-2B receptor genotyping; subjects who fall within one of the following groups: group 1: homozygote mutant: I/I (n=40); group 2: homozygote mutant: D/D (n=40)
排除标准
- •Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Treatment in the previous 3 weeks with any drug
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
- •History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
- •Blood donation during the previous 3 weeks
研究组 & 干预措施
1
homozygote mutant: Insertion/Insertion (40 patients)
干预措施: Brimonidine 0.2 % (Drug)
2
homozygote mutant: Deletion/Deletion (40 patients)
干预措施: Brimonidine 0.2 % (Drug)
结局指标
主要结局
alpha-2B receptor genotyping
时间窗: 20 minutes
Intraocular pressure (IOP)
时间窗: in total 10 minutes
次要结局
未报告次要终点