Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Pupil Diameter (mm) During Surgery
研究概览
简要总结
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Competent and willing to voluntarily provide informed consent
- •18 years of age or older
- •In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
- •Other inclusion criteria to be evaluated by the investigator
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 as the 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
- •Other exclusion criteria to be evaluated by the investigator
研究组 & 干预措施
OMS302 Solution
OMS302 Solution
干预措施: OMS302 Solution (Drug)
OMS302 Mydriatic Solution
OMS302 Mydriatic Solution
干预措施: OMS302 Mydriatic Solution (Drug)
OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution
干预措施: OMS302 Anti-inflammatory Solution (Drug)
Balanced Salt Solution (BSS) Solution
Balanced Salt Solution (BSS) Solution
干预措施: Balanced Salt Solution (BSS) Solution (Drug)
结局指标
主要结局
Pupil Diameter (mm) During Surgery
时间窗: During surgery (immediately prior to surgical incision to wound closure)
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
时间窗: through 12 hours post-surgery
For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
次要结局
- Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery(Two hours)
- Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery(Six hours)
- Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery(One day)
- Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery(14 days)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery(Two days)
- Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery(Two days)
- Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery(14 days)
- Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery(Six hours)
- Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery(Seven days)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery(Two hours)
- Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery(Two hours)
- Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination(Up to 30 days)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery(Two hours)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery(Two days)
- Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination(up to 30 days)
- Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery(Two hours)
- Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery(One day)
- Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery(Two days)
- Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery(Seven days)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery(Six hours)
- Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery(Two days)
- Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery(Seven days)
- Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination(Up to 30 days)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery(14 days)
- Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery(Seven days)
- Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery(14 days)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery(One day)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination(Up to 30 days)
- Best Corrected Visual Acuity (BVCA) - Log Score, Day 2(Two days)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery(One day)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery(Seven days)
- Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination(Up to 30 days)
- Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery(Six hours)
- Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery(One day)
- Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery(Six hours)
- Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery(14 days)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery(Six hours)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days(Seven days)
- Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery(Two hours)
- Best Corrected Visual Acuity (BVCA) - Log Score, Day 14(14 days)
- Best Corrected Visual Acuity (BVCA) - Log Score, Day 30(30 days)
- Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery(14 days)
- Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery(One day)
- Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery(Two days)
- Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination(Up to 30 days)
- Best Corrected Visual Acuity (BVCA) - Log Score, Baseline(Baseline)
- Best Corrected Visual Acuity (BVCA) - Log Score, Day 1(One day)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1(One day)
- Best Corrected Visual Acuity (BVCA) - Log Score, Day 7(Seven days)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery(Two hours)
- Postoperative Mean Anterior Chamber Cell Count, Day 2(Two days)
- Postoperative Use of Ophthalmic Anti-inflammatory Medications(up to 30 days)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline(Baseline)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7(Seven days)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14(14 days)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline(Baseline)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2(Two days)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30(30 days)
- Use of Pain Medications at Day 1(One day)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2(Two days)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1(One day)
- Use of Pain Medications After Day 1(up to 30 days)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14(14 days)
- Postoperative Mean Anterior Chamber Cell Count, Day 7(Seven days)
- Postoperative Mean Anterior Chamber Cell Count, Day 1(One day)
- Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30(30 days)
- Ocular Pain VAS Score After Day 0(43 days)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery(Two hours)
- Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7(Seven days)
- Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery(Two hours)
- Postoperative Mean Anterior Chamber Cell Count, Day 14(14 days)
- Postoperative Mean Anterior Chamber Cell Count, Day 30(30 days)