NCT01199510已完成4 期
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Ocular Comfort
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of FID 112903 (SYSTANE ULTRA® Lubricating Drops) plus standard of care to standard of care alone, in subjects with a history of intermittent eye irritation or dryness related to environmental factors and scheduled for routine 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
- Single (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
- •Patients must be at least 18 years of age
- •Patients must be seeking routine cataract extraction with monofocal intraocular lens implantation
排除标准
- •Patients for whom both eyes do not meet all inclusion criteria and either eye meets any exclusion criteria.
- •Patients cannot have a history of hypersensitivity to any component of FID
- •Patients cannot have previous intraocular or corneal surgery or any planned within 30 days.
- •Patients cannot use any ocular medications other than test article and standard of care post-op medications in past 14 days or during study.
- •Patients cannot be on chronic systemic corticosteroid or other immunosuppressive therapy.
- •Patients cannot have a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative Intraocular pressure >25 millimeters mercury in either eye.
- •Patients cannot have a history and/or current evidence of the following: clinically significant corneal scarring, blepharitis or macular pathology in either eye, Herpes zoster or Herpes simplex keratitis.
研究组 & 干预措施
Standard of Care plus FID 112903
Experimental
SYSTANE® ULTRA Lubricant Eye Drops dosed 4 times daily
干预措施: FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care (Other)
Standard of Care only
Active Comparator
Post Cataract Standard of Care Regimen
干预措施: Standard of Care (Other)
结局指标
主要结局
Ocular Comfort
时间窗: 30 days
Ocular comfort will be reported by the patient on a questionnaire
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry EyeDry Eye SyndromeNCT02446015Alcon Research159
已完成
不适用
Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device UsersOSDIDigital Eye StrainComputer Vision SyndromeNCT06505174University of Valladolid34
已完成
不适用
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface StainingDry Eye SyndromeNCT01863368Alcon Research105
撤回
不适用
Comparative Efficacy of SYSTANE® ULTRA vs Optive™ in Improving Tear Film Break-up TimeDry EyeNCT01417013Alcon Research
已完成
不适用
Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye DiseaseDry Eye DiseaseNCT03492541Alcon Research134