Tear Dynamics After Restasis Treatment in Dry Eye Patients Phase II Clinical Trial and Phase IIb 6-month Follow-up After Discontinuation of Study Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tear meniscus volume after treatment
研究概览
简要总结
Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.
详细描述
Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant will be eligible for entry in the study if s/he:
- •Is at least 18 years old and has full legal capacity to volunteer;
- •Has read and signed the IRB Informed Consent Document;
- •Is willing and able to follow participant instructions;
- •Has clear corneas;
- •Has 20/100 uncorrected visual acuity or better;
- •Has dry eye according to the study definition of DES (study subjects);
- •Has not use Restasis within 3 months.
排除标准
- •The subjects will ineligible for entry into the study if s/he:
- •Has any systemic disease affecting ocular health except for Sjögren's syndrome;
- •Is using any systemic or topical medications that will affect ocular health except for artificial tears;
- •Has an active ocular disease other than DES, or Sjögren's syndrome
- •Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
- •Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
- •Has worn rigid gas permeable lenses within 1 year and during the study;
- •Has had surgery or an eye injury within 6 months;
- •Was a soft contact lens wearer within 2 weeks and during the study.
结局指标
主要结局
Tear meniscus volume after treatment
时间窗: 3 months
Significant increase in tear meniscus volume was found in patients after 3 months of treatment.
Increase in tear volume after the 3-month treatment and returned to baseline during 6-month follow-up after discontinuation of study treatment.
时间窗: 3 months for treatment and follow-up of 6 months after discontinuation of study treatment.
次要结局
未报告次要终点
研究者
Jianhua (Jay) Wang, MD, PhD
Associate Professor
University of Miami