Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID)
详细描述
The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (LE) ophthalmic gel, 0.38% (BID) for the treatment of inflammation and pain following 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
- Double (Participant, 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
- •Visit 1 (Screening Visit)
- •Be willing and able to comply with all treatment and follow-up/study procedures.
- •Be a candidate for routine, uncomplicated cataract surgery.
- •Visit 3 (Postoperative Day 1)
- •Have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery) in the study eye.
- •Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.
排除标准
- •Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
- •Have known hypersensitivity or contraindication to the study drug(s) or their components.
研究组 & 干预措施
Loteprednol Etabonate Gel (BID)
Loteprednol Etabonate Gel 0.38% administered two times daily (BID)
干预措施: Loteprednol Etabonate Gel (BID) (Drug)
Vehicle Gel (BID)
Vehicle gel administered two times daily (BID)
干预措施: Vehicle Gel (BID) (Drug)
结局指标
主要结局
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells
时间窗: 8 days
White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = \> 30 cells. Lower score indicated better outcome. Complete resolution of AC cells was defined as cell score = 0 in the study eye.
Percentage of Participants With Grade 0 Pain in the Study Eye.
时间窗: 8 days
Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on the 6-point scale, with 0=None and 5=Severe.
次要结局
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and AC Flare in the Study Eye by Visit.(18 days)
- Percentage of Participants With Grade 0 Pain in the Study Eye by Visit.(18 days)
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells by Visit(18 days)
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye by Visit.(18 days)