A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
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
- •Moderate to severe dry eye disease in both eyes
- •Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
排除标准
- •Use of any cyclosporine preparations within 3 months
- •Use of topical medications, other than artificial tears, in the eyes within 1 month
- •Use of contact lenses in either eye within 1 month
- •Stage 2 only: Participation in Stage 1 of this study
研究组 & 干预措施
Stage 1 Cohort 5A
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
干预措施: Sham (Other)
Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 5A
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Vehicle (Drug)
Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 6C
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
干预措施: Vehicle (Drug)
Stage 1 Cohort 6C
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
Stage 1 Cohort 6D
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
干预措施: Vehicle (Drug)
Stage 1 Cohort 6D
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
干预措施: Cyclosporine New Ophthalmic Formulation (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: First dose of study drug to up to 24 Weeks
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
次要结局
未报告次要终点