NCT03440242已完成不适用
Biomarker Discovery in Two Daily Disposable Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Summary of Protein (Lysozyme) in Tears
研究概览
简要总结
This is a non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional study where subjects will be enrolled into one of four arms based on their habitual contact lenses. Subjects will be wearing their habitual contact lenses throughout the study and will be scheduled for morning and afternoon visits totaling 10 visits with a ~4-week washout period between visits 6 and 7.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Appear able and willing to adhere to a no lens wear period of at least one month.
- •Between 18 and 45 (inclusive) years of age at the time of screening.
- •Subject must be currently wearing one of the two habitual contact lenses in both eyes (1DAM or DACP) for at least three months. Habitual CL wear is defined as having a minimum wearing time of 3 hours per day, minimum of 3 days per week for at least 3 months.
- •Subject must have visual acuity of at least 20/40 or better in each eye with their habitual lenses
- •Subjects must meet one of the following criteria in order to be classified as either asymptomatic or symptomatic group:
- •Asymptomatic group: CLDEQ-8 score of ≤7, difference between CWT and AWT <1 hours/day
- •Symptomatic group: CLDEQ-8 score of ≥15, difference between CWT and AWT >3 hours/day
- •Have healthy eyes with no evidence of abnormality or disease (i.e., no active ocular pathological conditions/ infections of any type).
- •Have a pair of spectacles that provide corrected binocular visual acuity of 20/40 or better. If no spectacles, subjects must have un-aided binocular visual acuity of 20/40 or better.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating
- •Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- •Unacceptable lens fit with their habitual lenses in either eye based on study investigators judgment.
- •Any extended wear modality.
- •Use of systemic medications (e.g., chronic steroid use, immuno-suppressants or anti-infective medications) that are known to interfere with contact lens wear.
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Any previous, or planned (during the course of the study) intraocular/refractive surgery.
- •Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
- •Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear.
- •Participation in any interventional contact lens, eye drop or lens care product clinical trial within 30 days prior to study enrollment.
- •Suspicion of or recent history of alcohol or substance abuse, serious mental illness, or seizures.
- •Employee of clinical site (e.g., Investigator, Coordinator, Technician).
结局指标
主要结局
Summary of Protein (Lysozyme) in Tears
时间窗: Approximately 2 hours duration of assessment time
Summarizing potential differences in biomarker responses in tears of subjects wearing two different materials of daily disposable contact lenses. Lysozyme as biomarker in tears will be collected via Schirmer's strips and Capillary tubes at all scheduled visits and will be analyzed using Chromatography.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
不适用
Research study of ocular surface markers relationship to contact lens wearCTRI/2017/12/010950Johnson and Johnson Vision Care Inc
招募中
不适用
An exploratory research for biomarker and drug discovery seeds based on glaucoma database[0020]JPRN-UMIN000021778o institute3,000
招募中
不适用
Study of biomarker profiling to unravel the intertwined pathophysiology of coronary artery disease and abdominal aortic aneurysmAbdominal aortic aneurysm10002363NL-OMON53081Erasmus MC, Universitair Medisch Centrum Rotterdam440
已完成
不适用
A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart TransplantationHeart Transplant RejectionNCT03477383Vastra Gotaland Region134
已完成
不适用
Exploratory study to investigate biomarkers associated with pathogenesis of infantile hemangioma.Infantile hemangiomaJPRN-UMIN000038574Wakayama Medical University45