A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus 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
- Grade 0 for Pain
研究概览
简要总结
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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 who are candidate for routine, uncomplicated cataract surgery
- •Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
排除标准
- •Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
- •Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
- •Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
- •Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
研究组 & 干预措施
Loteprednol Etabonate
Loteprednol etabonate 0.5% ophthalmic ointment
干预措施: 0.5% Loteprednol Etabonate Ophthalmic Ointment (Drug)
Vehicle
Vehicle of loteprednol etabonate ointment
干预措施: Vehicle of Loteprednol Etabonate Ophthalmic Ointment (Drug)
结局指标
主要结局
Grade 0 for 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
Subjects 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.
次要结局
- Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.(At each follow-up visit through day18 (Visit 7))
- Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare(Baseline and each follow-up visit through day18 (Visit 7))