Effect of Age on Efficacy and Response Time of Latanoprost 0.005% in Patients With Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Pre-Treatment IOP (Intraocular Pressure)
研究概览
简要总结
Latanoprost is a commonly used treatment for glaucoma. Because of its mechanism of action, it is plausible that the age of a patient using the medication may affect its efficacy and time of onset.
We are going to study the effectiveness of Latanoprost in people of different ages, to see if it changes based on the age of the patient.
详细描述
Latanoprost is a topical ocular hypotensive medication with a well established safety and efficacy profile. Its effect is mediated by an increase in uveoscleral outflow, due to enzymatic degradation of the extracellular matrix within the ciliary muscle. Since the amount of extracellular matrix within the human eye increases with age, and uveoscleral outflow decreases with age, it would be expected that there should be a difference in the efficacy of latanoprost in patients of different ages. This has not been demonstrated in studies assessing the overall effect of latanoprost across adult age groups using multivariate analysis. (Camras CB et al, 1996).
However, a difference in timing of onset of drug effect may get overlooked in clinical studies and in clinical practice as well, as patients tend to be seen from two to eight weeks after initiation of treatment, by which time any differences in response time may have already occurred and leveled off.
To our knowledge, there are no studies specifically looking at the timing of onset of drug effect of latanoprost in different age groups. Because of the theoretical plausibility of this effect based on the mechanism of action of latanoprost, this represents an opportunity to further elucidate the characteristics of this medication in a manner which has clinical and scientific relevance.
Our aim is thus to determine if there is a difference in timing of onset of the ocular hypotensive effect of latanoprost in glaucoma patients of different age groups.
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
- •diagnosis of open angle glaucoma,
- •pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
- •IOP above their target pressure as determined by a glaucoma specialist;
- •willingness to participate in the study.
排除标准
- •hypersensitivity to any of the components of the treatment medication;
- •previous use of topical prostaglandins;
- •documented ocular infection or intraocular inflammation within the past year;
- •previous filtering surgery or complicated cataract surgery;
- •active corneal disease;
- •presence of cystoid macular edema;
- •laser trabeculoplasty or any other ocular laser procedure within the past three months.
研究组 & 干预措施
1
All participants will be taking Latanoprost; This study compares efficacy within age groups.
干预措施: Latanoprost 0.005% (Drug)
结局指标
主要结局
Pre-Treatment IOP (Intraocular Pressure)
时间窗: At baseline (before treatment)
Subjects applied topical latanoprost at bedtime for 8 weeks
Post-Treatment IOP (Intraocular Pressure)
时间窗: 8 Weeks
Subjects applied topical latanoprost at bedtime for 8 weeks
次要结局
未报告次要终点
