A Phase I/II Prospective, Randomized, Double Masked, Vehicle And Comparator Controlled, Dose Ranging Study Of CP-690,550 In Subjects With Dry Eye Disease.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 327
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Systemic Adverse Events (AEs)
研究概览
简要总结
A prospective, randomized, placebo and active comparator controlled study of CP-690,550 in subjects with dry eye.
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
- •Symptoms of dry eye for at least 6 months.
- •Signs of moderate to severe dry eye
排除标准
- •Women who are nursing or pregnant
- •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 1
干预措施: CP-690,550 (Drug)
Treatment 3
干预措施: CP-690,550 (Drug)
Treatment 4
干预措施: CP-690,550 (Drug)
Active comparator
干预措施: Cyclosporine (Drug)
Treatment 2
干预措施: CP-690,550 (Drug)
Placebo
干预措施: CP-690,550 Vehicle (Drug)
结局指标
主要结局
Percentage of Participants With Systemic Adverse Events (AEs)
时间窗: Baseline up to Week 8
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs are the events which are not localized but occur throughout the systemic circulation.
Percentage of Participants With Ocular Adverse Events (AEs)
时间窗: Baseline up to Week 8
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Ocular Tolerability Assessment
时间窗: Baseline up to Week 8
Ocular tolerability assessment included evaluation of severity and duration of the 5 symptoms: burning/stinging, blurred vision, ocular discomfort, pain, tearing. Severity was assessed on a 4-point scale, where 0=none, 1=mild, 2=moderate and 3=severe. Duration was assessed as immediate (if subsided within 5 minutes \[\<5 min\] after application) or persistent (if continued beyond 5 minutes \[\>=5 min\] after application).
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 10 Millimeter (mm) Schirmer Wetting Score Without Anesthesia at Week 8
时间窗: Week 8
Schirmer test without anesthesia: well standardized test used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac for 5 min. The length of wetting was recorded to the nearest 0.5 millimeter (mm). If the wetting line was oblique, halfway point was used. Results from study eye are reported. Study eye is the 'worse eye', defined as the eye with worse Schirmer test score without anesthesia score at baseline.
次要结局
- Time to Achieve >= 10mm Schirmer Test Score Without Anesthesia(Baseline through Week 8)
- Time to Achieve 100 Percent (%) Clearance of Corneal Staining(Baseline through Week 8)
- Time to Achieve >= 5 Units Decrease in Ocular Comfort Index (OCI) Score(Baseline through Week 8)
- Change From Baseline in Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Schirmer Wetting Score With Anesthesia at Week 8(Baseline, Week 8)
- Change From Baseline Ocular Surface Disease Index (OSDI) Raw Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score Without Anesthesia at Week 1, 2, 4 and 6(Week 1, 2, 4, 6)
- Percentage of Participants Who Achieved >=10 mm Schirmer Wetting Score With Anesthesia at Week 8(Week 8)
- Change From Baseline in Corneal Staining Scores at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants Who Demonstrated 100% Clearance of Corneal Staining(Week 1, 2, 4, 6, 8)
- Change From Baseline in Interpalpebral Conjunctival Staining Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Tear Break-up Time (TBUT) at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Ocular Comfort Index (OCI) Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants With >= 5 Units Decrease in Total OCI Score(Week 1, 2, 4, 6, 8)
- Change From Baseline in Daily Artificial Tear Use at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in Ocular Surface Disease Index (OSDI) Total and Subscale Score at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Percentage of Participants With >= 10 Units Decrease in Total OSDI Score(Week 1, 2, 4, 6, 8)
- Change From Baseline in Modified Ocular Comfort Index (mOCI) Raw Scores at Week 1, 2, 4, 6 and 8(Baseline, Week 1, 2, 4, 6, 8)
- Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Score (NEI-VFQ-25) at Week 8(Baseline, Week 8)