NCT00828477已完成4 期
Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Tolerability of study medication
研究概览
简要总结
The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.
详细描述
Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •> 18 years old, either gender or any race.
- •Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty.
- •Completion of written and informed consent/authorization prior to any study related procedures.
- •Able to follow study protocol and likely to complete study schedule.
排除标准
- •Known sensitivity to NSAIDs.
- •History of neovascular or ocular inflammatory disease.
- •Current use of topical or systemic anti-inflammatory medications.
- •Females of childbearing potential.
研究组 & 干预措施
1
Active Comparator
Xibrom (bromfenac)
干预措施: Xibrom (Drug)
2
Active Comparator
Nevanac (nepafenac)
干预措施: Nevanac (Drug)
结局指标
主要结局
Tolerability of study medication
时间窗: 28 days
次要结局
- Intraocular pressure changes(28 days)
- Visual Acuity(28 days)
研究者
研究点 (1)
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