NCT00945958已完成3 期
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Number of Subjects With AEs
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.
详细描述
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.
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
- 否
入选标准
- •Men and women aged ≥18 years
- •Willing to participate and giving written informed consent
- •Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
- •Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma
排除标准
- •History of allergic hypersensitivity or poor tolerance to latanoprost
- •History of Substance abuse or addiction (alcohol drugs) in the past 3 years
- •History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
- •Any abnormality preventing IOP measurement
研究组 & 干预措施
SPARC0913
Experimental
干预措施: SPARC0913 (Drug)
结局指标
主要结局
Number of Subjects With AEs
时间窗: 24 weeks
Subjects with treatment emergent adverse events
次要结局
- Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)(24 weeks)
研究者
研究点 (1)
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