CTRI/2017/12/010950尚未招募未知
Biomarker Discovery in Two Daily Disposable Contact Lenses
Johnson and Johnson Vision Care Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •2. Appear able and willing to adhere to the instructions set forth in this clinical protocol
- •3. Appear able and willing to adhere to a no lens wear period of at least a month. 4. Between 18 and 45 (inclusive) years of age at the time of screening
- •5. 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.
- •6. 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:
- •a. Asymptomatic group: CLDEQ-8 score of <=7, difference between CWT and AWT <1 hours/day
- •b. Symptomatic group: CLDEQ-8 score of >=15, difference between CWT and AWT >3 hours/day
- •8. Have healthy eyes with no evidence of abnormality or disease (i.e., no active ocular pathological conditions/ infections of any type).
- •9. Have a pair of spectacles that provide corrected binocular visual acuity of 20/40 or better. If no spectacles, subjects must have unaided binocular visual acuity of 20/40 or better.
排除标准
- •Currently pregnant or lactating
- •2. Any diseases (e.g., Sjögrenâ??s Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), diabetes, or other diseases, by self-report, which are known to interfere with contact lens wear and/or
- •participation in the study.
- •3. Unacceptable lens fit with their habitual lenses in either eye based on study investigators judgment
- •4. Any extended wear modality
- •5. Use of systemic medications (e.g., chronic steroid use, immunosuppressants
- •or anti-infective medications) that are known to interfere with contact lens wear
- •6. 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 styles, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •7.Any previous, or planned (during the course of the study) intraocular/refractive surgery
- •8. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
- •9. 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 within the past 6 months
- •10. Participation in any interventional contact lens, eye drop or lens care product clinical trial within 30 days prior to study enrollment
- •11. Suspicion of or recent history of alcohol or substance abuse, serious mental illness, or seizures.
- •12. Employee of clinical site (e.g., Investigator, Coordinator, Technician)
研究者
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