Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
研究概览
简要总结
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation 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
- •Subjects at least 18 years of age
- •Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- •Subjects who are candidate for routine, uncomplicated cataract surgery.
- •Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
- •Subjects must be willing and able to comply with all treatment and follow- up procedures.
排除标准
- •Subjects who have known hypersensitivity or contraindication to the study drug or its components.
- •Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
- •Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
- •Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
- •Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
- •Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
- •Women who are pregnant or breast feeding.
- •Subjects who have participated in an investigational drug or device study within the last 30 days.
- •Subjects previously randomized in this study.
研究组 & 干预措施
Loteprednol Etabonate
Loteprednol Etabonate 0.5%
干预措施: Loteprednol Etabonate (Drug)
Vehicle
Vehicle of Ophthalmic Loteprednol Etabonate
干预措施: Vehicle of Ophthalmic Loteprednol Etabonate (Drug)
结局指标
主要结局
Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
时间窗: Postoperative day 8 (Visit 5)
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Participants With Grade 0 (no) Pain
时间窗: Postoperative day 8 (Visit 5)
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
次要结局
- Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare(Postoperative Day 3-18 (Each follow-up Visit 4-7))
- Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.(At each visit: Visit 4-7, postoperative days 3-18)