NCT01882413已完成不适用
A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 204
- 主要终点
- Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
研究概览
简要总结
This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo cataract removal surgery
排除标准
- •Current use of eye drops or oral medications for allergic conjunctivitis
- •Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
- •Use of a contact lens within 4 weeks
结局指标
主要结局
Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
时间窗: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
次要结局
- Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9(Up to 60 days prior to cataract surgery)
- Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention(Up to 60 days prior to cataract surgery)
- Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining(Up to 60 days prior to cataract surgery)
- Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs(Up to 60 days prior to cataract surgery)
- Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms(Up to 60 days prior to cataract surgery)
- Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms(Up to 60 days prior to cataract surgery)
- Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears(Up to 60 Days Prior to Surgery)
- Percentage of Participants With Elevated MMP-9 With Punctal Plugs(Up to 60 Days Prior to Surgery)
- Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2(Up to 60 Days Prior to Surgery)
- Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32(Up to 60 Days Prior to Surgery)
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