A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
- 主要终点
- Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) 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
- •Competent and willing to voluntarily provide informed consent
- •18 years of age or older
- •In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia
排除标准
- •No allergies to the medications and/or the active ingredients of any of the study medications
- •No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
- •No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
研究组 & 干预措施
OMS302
OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
干预措施: OMS302 (Drug)
Placebo
Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery
时间窗: from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)
Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute). The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
次要结局
- Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively(12 hours)
- Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)(Six hours postoperatively)
- Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)(One day)
- Best Corrected Visual Acuity (BVCA) Log Score on Day 1(One day)
- Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1(One day)
- Ocular Pain VAS Score After Day of Surgery - Day 1(One day)