The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure From Baseline at Visit 3
研究概览
简要总结
The aim of this study will be to determine the effects of pilocarpine as an adjunct medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and compare these effects to latanoprost alone.
详细描述
This study plans to learn more about the effect of pilocarpine on intraocular pressure and ocular perfusion pressure for a full twenty-four hour period.
In this study, the investigators seek to better characterize the knowledge base of the intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP, but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP - diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of pilocarpine and help determine if this medication has a useful role as an adjunctive treatment in glaucoma.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current confirmed diagnosis of:
- •open angle glaucoma, or
- •ocular hypertension including pigment dispersion glaucoma, and
- •pseudoexfoliation glaucoma.
- •Current use of topical latanoprost once a day in both eyes for at least 6 weeks
- •any race/ethnicity
排除标准
- •Females who are currently pregnant or planning to become pregnant during the study period
- •Diagnosis of any other form of glaucoma other than open-angle
- •Intraocular pressure readings of <14mmHg in either eye when measured during routine office visit in the past 12 months.
- •Schaffer angle grade < 2 in either eye by gonioscopy
- •Intraocular surgery within 6 months or laser within 3 months
- •History of retinal tear or detachment in either eye
- •Active iritis in either eye as determined by most recent eye examination
- •Patients who smoke or have irregular daily sleep patterns
- •Patients who have started or changed glucocorticoids therapy in the last 3 months
- •Patients who are currently using medical or recreational marijuana
- •Any use of a non-FDA approved medication for glaucoma in the last 3 months
研究组 & 干预措施
Pilocarpine group
Subjects with open-angle glaucoma and ocular hypertension that are currently taking latanoprost
干预措施: Pilocarpine (Drug)
结局指标
主要结局
Change in Intraocular Pressure From Baseline at Visit 3
时间窗: Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3
Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA
次要结局
- Change in Ocular Perfusion Pressure(Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3)