Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change from baseline in total corneal staining
研究概览
简要总结
The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.
详细描述
After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Sjogren's Syndrome.
- •Self-reported complaints of ocular dryness for a period of at least 3 months
- •Best-corrected distance visual acuity of 20/25 or better in each eye.
排除标准
- •Use of cyclosporine within the last 3 months.
- •Use of ocular steroid within the 3 months.
- •Previous history of treatment failure with cyclosporine.
- •Known hypersensitivity or contraindication to the study medication or any of its ingredients.
- •Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
- •Any active ocular infection.
- •Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up.
- •History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study.
- •Currently pregnant or lactating.
研究组 & 干预措施
Cyclosporine
Participants receive Cyclosporine 0.09% Ophthalmic Solution (Cequa), 1 drop, each eye, twice a day for 12 weeks
干预措施: Cyclosporine 0.09% Ophthalmic Solution (Drug)
结局指标
主要结局
Mean change from baseline in total corneal staining
时间窗: Baseline and week 12
Expanded NEI corneal staining scale ranging from 0 to 15
次要结局
- Mean change from baseline in total conjunctival staining(Baseline and week 12)
- Mean change from baseline in the score of dry eye questionnaires(Baseline and week 12)