NCT01779778已完成不适用
The Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in Intraocular Pressure
研究概览
简要总结
The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.
详细描述
The investigators hypothesize that Travatan Z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. The investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma
- •Age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity
排除标准
- •Females who are currently pregnant or planning to become pregnant, as determined by history during the study period
- •Diagnosis of any other form of glaucoma other than open-angle
- •Schaffer angle grade < 2 in either eye by gonioscopy
- •Chronic, recurrent, or severe inflammatory eye disease
- •Intraocular surgery within 6 months or laser within 3 months
- •History of active, recurrent, or chronic ocular infection with the Herpes Simplex Virus
- •History of cystoid macular edema
- •Inability to safely discontinue all ocular medications for 4 weeks
- •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 undergoing medical marijuana therapy
- •Any use of a non-FDA approved medication for glaucoma in the last 3 months
结局指标
主要结局
Changes in Intraocular Pressure
时间窗: Every 2 hours for 24 hours
To determine the 24-hour intraocular pressure lowering effect of Travatan Z
次要结局
- Intraocular Pressure Change Duration(72 hours)
研究者
研究点 (1)
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