NCT07510620招募中4 期
Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear
Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dry eye signs
研究概览
简要总结
This research study is to see if using Lacrifill is safe, easy to use, and helpful for people who wear contact lenses but can't wear them comfortably for long. Specifically, the study aims to determine whether regular use of Lacrifill over a 2-3 month period can help people wear their contacts longer without discomfort and reduce signs and symptoms of dry 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>21 years of age
- •Contact lens wearer
- •Previous Dry Eye Treatment
- •Be on a stable dose of antihistamines/Birth Control Medication and Lifitegrast and cyclosporine.
- •Schrimers Anesthetized less than or equal to 10
- •CLDEQ-8 greater than or equal to 12
- •Corneal Staining NEI grading scale greater than or equal to 1
排除标准
- •Known allergy to Hyaluronic Acid
- •Current topical ophthalmic drops other than dry eye treatment
- •Uncontrolled Diabetes
- •Diabetic Retinopathy
- •Pregnancy or Lactating
- •Corneal Surgery (except Refractive)
- •Corneal Scars
- •Keratoconus
- •Ocular Herpetic Keratitis
研究组 & 干预措施
Lacrifill
Experimental
干预措施: Lacrifill (Drug)
结局指标
主要结局
Dry eye signs
时间窗: 2-3 months
To asses the effect of Lacrifill.
Dry Eye Symptoms
时间窗: 2-3 Months
To asses the effect of Lacrifill.
Contact Lens Tolerability
时间窗: 2-3 Months
To asses the effect of Lacrifill.
次要结局
- Evaluate Changes in CLDEQ-8 Questionnaire(2-3 Months)
- Evaluate the Changes in the OSDI Questionnaire(2-3 Months)
- Evaluate changes in Contact Lens Wear Time(2-3 Months)
- Evaluate Clinical Signs of Tear Break Up Time(2-3 Months)
- Evaluate Clinical Signs of Corneal Staining(2-3 Months)
- Evaluate clinical Signs of Schirmer's Tear Test(2-3 Months)
研究者
研究点 (1)
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