NCT00631358已完成4 期
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Change in Levels of Biomarkers After Dosing With Maxidex
研究概览
简要总结
The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •17 years or older
- •LogMar visual acuity of 0.6 or better
- •Ocular inflammation associated with Sjogren's Syndrome
排除标准
- •Has had an adverse reaction to either topical of systemic steroids in the past
- •Has diabetes (type 1 or 2)
- •Has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of Visit 1
- •Has worn contact lenses within one week prior to Visit 1
- •Has received ocular prescription therapy in the last 30 days
- •Has active ocular infections or inflammation not associated with Sjogren's Syndrome.
- •Has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant
研究组 & 干预措施
Maxidex
Experimental
Maxidex
干预措施: Maxidex (Drug)
No treatment
Sham Comparator
Healthy normal control group receiving no treatment
干预措施: No treatment (Other)
结局指标
主要结局
Change in Levels of Biomarkers After Dosing With Maxidex
时间窗: Baseline to 2 weeks
Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.
次要结局
- Correlation Between Biomarker Expression and Ocular Symptoms(Baseline to 2 weeks)
- Correlation Between Biomarker Expression and Tear Film Break up Time(Baseline to 2 weeks)
- Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining(Baseline to 2 weeks)
- Correlation Between Biomarker Expression and the Schirmer Test(Baseline to 2 weeks)
研究者
研究点 (2)
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