NCT00833235已完成不适用
A Natural History Study of Patients With Dry Eye
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
- 284
- 试验地点
- 17
- 主要终点
- Percentage of Patients with Progression of Dry Eye Disease
研究概览
简要总结
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
- •Baseline OSDI score of ≥ 13
- •Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
排除标准
- •Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
- •History of herpes keratitis or varicella zoster keratitis
- •Any history of allergic conjunctivitis
- •Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
- •Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
- •Patients with known systemic disease
- •Any history of corneal transplant
结局指标
主要结局
Percentage of Patients with Progression of Dry Eye Disease
时间窗: Baseline, 60 Months
次要结局
- Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score(Baseline, 60 Months)
- Percentage of Patients with an Increase in Blurred Vision(Baseline, 60 Months)
- Change from Baseline in Schirmer's Test(Baseline, 60 Months)
- Change from Baseline in Conjunctival Staining Score on a 6-Point Scale(Baseline, 60 Months)
- Change from Baseline in Corneal Staining Score on a 6-Point Scale(Baseline, 60 Months)
研究者
研究点 (17)
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