Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery in Adult Chinese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Proportion of Subjects With Clinical Cure at Day 14
研究概览
简要总结
The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects.
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
- Single (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
- •Adult Chinese subjects, 18 years of age or older, of either sex who have a cataract, and are expected to undergo cataract extraction with the implantation of a posterior chamber intraocular lens;
- •Study eye of subjects, who in the opinion of the Investigator, will have improvement in best-corrected visual acuity after surgery;
- •Subjects should be able to understand and sign an informed consent that has been approved by an Independent Ethics Committee;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Use of topical ocular or systemic steroids within 14 days prior to surgery;
- •Use of topical ocular or systemic non-steroidal anti-inflammatory drugs within 7 days of surgery, except an allowed daily dose of baby aspirin (81 mg);
- •Subjects planning to have cataract surgery in their fellow, non-study eye prior to the 14 day postoperative study visit;
- •Any intraocular inflammation or ocular pain greater than Grade 0 in the study eye that is present during the baseline slit-lamp exam;
- •Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist:
- •they are breast feeding;
- •they have a positive urine pregnancy test at baseline;
- •they are not willing to undergo a urine pregnancy test upon exiting the study;
- •they intend to become pregnant during the duration of the study; or,
- •they do not agree to using adequate birth control methods for the duration of the study.
- •Any abnormality that prevents reliable tonometry;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Lens pseudoexfoliation syndrome with glaucoma or zonular compromise;
- •Previous ocular trauma to the operative eye;
- •A history of chronic or recurrent inflammatory eye disease;
- •Ocular infection or ocular pain;
- •Proliferative diabetic retinopathy;
- •Uncontrolled diabetes mellitus;
- •Congenital ocular anomaly;
- •Iris atrophy in the operative eye;
- •A nonfunctional fellow eye;
- •Use of an investigational intraocular lens;
- •Participation in any other clinical study within 30 days before surgery;
- •Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory agents, or to any component of the study medication;
- •Subjects with known bleeding tendencies, or who are receiving medications that may prolong bleeding time, may be enrolled at the physician's discretion; continuation of previous therapy for these subjects will be left to the judgment of the physician;
- •The fellow eye of an individual currently or previously enrolled in the study;
- •Subjects using a topical ophthalmic prostaglandin;
- •Subjects, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Nepafenac
Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
干预措施: Nepafenac Ophthalmic Suspension, 0.1% (Drug)
Placebo
Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
干预措施: Nepafenac Vehicle Ophthalmic Solution (Other)
结局指标
主要结局
Proportion of Subjects With Clinical Cure at Day 14
时间窗: Day 14 postoperative
Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (\>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.
次要结局
- Proportion of Subjects Who Were Pain-Free at All Postoperative Visits(Up to Day 14)