NCT00814944已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
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
- Santen Inc.
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Mean corneal fluorescein staining (inferior region) after CAE exposure.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Group 1
Experimental
干预措施: Sirolimus (Drug)
Dose Group 2
Experimental
干预措施: Sirolimus (Drug)
Dose Group 3
Experimental
干预措施: Sirolimus (Drug)
Dose Group 4
Placebo Comparator
干预措施: Sirolimus (Drug)
结局指标
主要结局
Mean corneal fluorescein staining (inferior region) after CAE exposure.
时间窗: Day 28
Mean ocular discomfort during CAE exposure.
时间窗: Day 28
次要结局
- Safety across treatment groups.(Through 28 days)
- Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity.(Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular DegenerationAge-Related Macular DegenerationChoroidal NeovascularizationNCT00766337Santen Inc.62
已完成
2 期
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular EdemaDiabetic Macular EdemaNCT00656643Santen Inc.131
终止
1 期
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular DegenerationChoroidal NeovascularizationAge-related Macular DegenerationNCT00712491Santen Inc.20
终止
2 期
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis ComplexAngiofibroma of FaceTuberous SclerosisNCT03363763Aucta Pharmaceuticals, Inc24
已完成
2 期
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis SiccaKeratoconjunctivitis SiccaNCT00128245Novartis440