NCT02329743已完成2 期
A Multicenter, Double-Masked, Parallel-Group, Vehicle-Controlled Study to Assess the Efficacy and Safety of RX-10045 Nanomicellar Ophthalmic Solution for Treatment of Ocular Inflammation and Pain in Subjects Undergoing Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Proportion of Subjects With Clearing of Anterior Inflammation
研究概览
简要总结
The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag.
排除标准
- •Any additional surgical procedures at the time of the cataract surgery
- •Refractive surgery in the study eye within the past 2 years
- •History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye
- •Intraocular pressure of > 21 mm Hg in either eye
- •Proliferative or severe nonproliferative diabetic retinopathy in either eye
- •Neovascular/wet age-related macular degeneration in either eye
研究组 & 干预措施
RX-10045 0.05% nanomicellar solution
Experimental
topical eye drops
干预措施: RX-10045 (Drug)
RX-10045 0.1% nanomicellar solution
Experimental
topical eye drops
干预措施: RX-10045 (Drug)
Vehicle
Placebo Comparator
topical eye drops
干预措施: RX-10045 (Drug)
结局指标
主要结局
Proportion of Subjects With Clearing of Anterior Inflammation
时间窗: Day 8
score of zero for the Standardization of Uveitis Nomenclature scale
次要结局
- Proportion of Subjects Reporting no Ocular Pain(Day 3)
研究者
研究点 (1)
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