NCT01135511已完成2 期
A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
研究概览
简要总结
The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective symptoms of dry eye for at least 6 months
- •Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)
排除标准
- •Women who are nursing, pregnant or planning pregnancy during the study
- •Participation in other studies within 30 days of screening visit
- •Ocular disorders that may confound interpretation of study results
研究组 & 干预措施
Treatment 5
Active Comparator
干预措施: Sodium Hyaluronate (Drug)
Treatment 2
Experimental
干预措施: CP-690,550 Eye drops (Drug)
Treatment 1
Experimental
干预措施: CP-690,550 Eye drops (Drug)
Treatment 4
Placebo Comparator
干预措施: CP-690,550 Eye drops-vehicle (Drug)
Treatment 3
Experimental
干预措施: CP-690,550 Eye drops (Drug)
结局指标
主要结局
Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8
时间窗: Baseline, Week 8
Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline. Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.
次要结局
- Changes in Corneal Staining Scores for Study Eye From Baseline(Baseline, Week 1, 2 and 4)
- Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye(Week 1, 2, 4 and 8)
- Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline(Baseline, Week 1, 2, 4 and 8)
- Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline(Baseline, Week 1, 2, 4 and 8)
- Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline(Baseline, Week 1, 2, 4 and 8)
- Percentage of Participants Who Achieve ≥10 mm Schirmer Test Value Without Anesthesia for Study Eye(Week 1, 2, 4 and 8)
- Number of Participants Who Increase of ≥10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye(Week 1, 2, 4 and 8)
- Changes in the Ocular Comfort Index (OCI) Total Score From Baseline(Baseline, Week 1, 2, 4 and 8)
- Number of Participants Demonstrating at Least ≥3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline(Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline(Baseline, Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms(Baseline, Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function(Baseline, Week 1, 2, 4 and 8)
- Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers(Baseline, Week 1, 2, 4 and 8)
- Percentage of Participants Demonstrating ≥10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline(Week 1, 2, 4 and 8)
- Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye(Week 8)
- Number of Participants Evaluable for Time to Achievement of ≥10 mm Schirmer Wetting Score Without Anesthesia for Study Eye(Week 8)
- Number of Participants Evaluable for Time to Achievement of ≥3 Unit Decrease in OCI Scores(Week 8)
- Number of Participants With Ocular Adverse Events (AEs)by Severity(8 weeks)
- Number of Participants With Nonocular Adverse Events (AEs) by Severity(8 weeks)
- Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale(8 weeks)
研究者
研究点 (1)
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