NCT00724412已完成4 期
Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 279
- 主要终点
- Tear Break-up time
研究概览
简要总结
Comparison of two Dry Eye products
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
- None
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
- •Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.
- •Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.
- •Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.
排除标准
- •Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
- •Use of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit
- •Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
- •Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.
- •Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
- •Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period.
- •Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).
研究组 & 干预措施
Optive
Active Comparator
Optive
干预措施: Optive (Other)
Systane
Active Comparator
Systane
干预措施: Systane (Other)
结局指标
主要结局
Tear Break-up time
时间窗: 42 days
次要结局
未报告次要终点
研究者
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