NCT00539526已完成4 期
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 106
- 主要终点
- Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
研究概览
简要总结
This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension
排除标准
- •Known contraindication to latanoprost, bimatoprost or travoprost
- •Uncontrolled systemic disease
- •Active ocular disease other than glaucoma or ocular hypertension
- •Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
研究组 & 干预措施
1
Experimental
bimatoprost 0.03%
干预措施: Bimatoprost 0.03% (Drug)
2
Active Comparator
travoprost 0.004%
干预措施: travoprost 0.004% (Drug)
3
Active Comparator
latanoprost 0.005%
干预措施: latanoprost 0.005% eye drops (Drug)
结局指标
主要结局
Change From Baseline in Mean Conjunctival Hyperemia Scores at Month 3
时间窗: Baseline, Month 3
Change from baseline in mean conjunctival hyperemia scores at month 3. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded using a 5-point scale in which 0=no redness and +3=deep, diffuse redness. A negative number change from baseline indicates improvement.
次要结局
- Change From Baseline in Corneal Staining With Fluorescein at Month 3(Baseline, Month 3)
- Change From Baseline in Tear Break-Up Time (TBUT) at Month 3(Baseline, Month 3)
研究者
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