NCT01733732已完成不适用
Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
研究概览
简要总结
The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.
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
- Double (Participant, 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
- •Read, sign, and date the Informed Consent Document;
- •Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1;
- •Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1);
- •Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months;
- •Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs);
- •History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; 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 any concomitant topical ocular medications during the study period;
- •Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire study period;
- •Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1 and that remains stable throughout the study;
- •Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Systane Balance
Experimental
SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days
干预措施: SYSTANE® BALANCE Lubricant Eye Drops (Other)
Systane Gel
Active Comparator
SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days
干预措施: SYSTANE® Gel (Other)
结局指标
主要结局
Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
时间窗: Baseline (Day 0), Day 14, Day 30
The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.
次要结局
- Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit(Baseline (Day 0), Day 14, Day 30)
- Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit(Baseline (Day 0), Day 14, Day 30)
- Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit(Baseline (Day 0), Day 14, Day 30)
- Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit(Baseline (Day 0), Day 14, Day 30)
- Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30(Baseline (Day 0), Day 30)
- Percentage of Eyes With Normal Slit-lamp Assessment(Baseline (Day 0), Day 14, Day 30)
- Mean Change From Baseline in Ocular Surface Staining by Visit(Baseline (Day 0), Day 14, Day 30)
- Meibomian Gland Expression(Baseline (Day 0), Day 14, Day 30)
- Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30(Baseline (Day 0), Day 30)
- Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30(Baseline (Day 0), Day 30)
- Mean Change From Baseline in Intraocular Pressure (IOP) by Visit(Baseline (Day 0), Day 14, Day 30)
研究者
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