NCT00047554终止不适用
A Five-Year, Multicenter, Commercial Label Safety Study of TRAVATAN® 0.004% in Patients With TRAVATAN-Induced Iris Pigmentation Changes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 336
- 主要终点
- Change in Iris Pigmentation from Baseline for Study Eye by Visit
研究概览
简要总结
The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TRAVATAN
Travoprost, 0.004% ophthalmic solution, 1 drop to the study eye once daily in the evening for up to 5 years
干预措施: Travoprost, 0.004% ophthalmic solution (Drug)
结局指标
主要结局
Change in Iris Pigmentation from Baseline for Study Eye by Visit
时间窗: Baseline, Up to Year 5
As assessed by ocular photography
次要结局
- Incidence of Change in Eyelash Characteristic from Baseline for Study Eye by Visit(Baseline, Up to Year 5)
研究者
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