A Single-Center Pilot Study To Evaluate the Effects of a Challenge Model on Mucin 16 Levels in Dry Eye Subjects Compared to Normal Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Mucin levels assayed from collected tears
研究概览
简要总结
The purpose of this study is to evaluate changes in ocular mucin levels in response to a drying environment in subjects with dry eye disease as well as patients who report no history of dry eye disease.
It is expected that exposure to the dry environment will alter mucin levels in different ways when comparing the two groups.
详细描述
This is a single-center, two visit, pilot, drying environment study (CAE). There will be two different groups of subjects enrolled into this study: dry eye subjects and subjects with no prior diagnosis of dry eye.
All subjects will undergo safety and dry eye assessments as well as tear collection prior to and after being exposed to a dry environment. They will also return the following day to undergo dry eye assessments, tear collection, and safety procedures again.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female of any race, at least 18 years of age at Visit
- •Have provided verbal and written informed consent.
- •Have a best corrected visual acuity of +0.70 logMAR or better in both eyes at Visit 1, as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
- •If a woman of childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to use a medically acceptable form of birth control throughout the study duration . [Females are considered of childbearing potential unless they are surgically sterilized (bilateral tubal ligation, hysterectomy or bilateral oophorectomy) or post-menopausal (at least 12 months since last menses).]
- •Have previously completed a recent trial OR not completed a recent trial AND report no symptoms of dry eye disease.
排除标准
- •Have planned surgery during trial period
- •Female currently pregnant, planning a pregnancy or lactating
- •Use of disallowed medications
- •Have ocular infections, or ocular conditions that could affect study parameters
- •Have used an investigational drug or device within 30 days of start of study
- •Female that is currently pregnant, planning a pregnancy or lactating
结局指标
主要结局
Mucin levels assayed from collected tears
时间窗: 24 hours after being exposed to the CAE
Tears will be collected and mucin will be measured 24 hours after being exposed to the CAE.
次要结局
- Blink Rate Analysis(24 hours post-CAE)
- Symptom Collection(24 hours post-CAE)
- Schirmer's Test(End of Visit 2 (Day 1 of study))
- Fluorescein staining(24 hours post-CAE)
- Tear Film Break Up Time(24 hours post-CAE)
- Lissamine staining(24 hours post-CAE)
- Presence of conjunctival redness(24 hours post-CAE)
- Ora Calibra Ocular Protection Index 2.0(24 hours post-CAE)