Improving Drop Instillation Comfort of a Cyclosporine A Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).
研究概览
简要总结
Patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine A that help with reducing inflammation. The newest eye drop containing cyclosporine A is called Cequa (Sun Pharma, Canada). Unfortunately, nearly a quarter of (24.2%) of patients using Cequa have reported some form of discomfort (burning and stinging) when instilling the drops. This potentially discourages patients from continuing the eye drop, which prevents their dry eye disease from being managed effectively. This study is trying to determine if refrigerating the eye drops would allow the drops to feel more comfortable when they are instilled in the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Over 18 years of age.
- •Ocular Surface Disease Index score >=
- •Strip meniscometry < 5 mm.
排除标准
- •Contact lens wearers.
- •Have corneal neuropathic or neurotrophic disease.
- •Have an ocular or medical condition or taking medications that could confound a study outcome.
- •Currently pregnant or breastfeeding (cyclosporine is a FDA pregnancy Category C drug).
- •Have an ocular or medical condition for which Cequa is contraindicated (e.g., allergy to cyclosporine or other ingredients in Cequacurrent eye infection, cancer or precancerous condition in or around the eyes).
- •Have an allergy to fluorescein.
研究组 & 干预措施
All participants
All participants will have a refrigerated 0.09% cyclosporine drop instilled in one eye, and a non-refrigerated 0.09% cyclosporine drop instilled in the other eye. The eye that receives the refrigerated drop is randomly determined.
干预措施: 0.09% cyclosporine A ophthalmic solution (Drug)
结局指标
主要结局
Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).
时间窗: Within 10 minutes of drop instillation
Difference in ocular discomfort between the eye that receives a refrigerated Cequa drop and the eye that receives a non-refrigerated (room temperature) drop.
次要结局
未报告次要终点