ACTRN12621000520831招募中未知
The behaviour of and change to corneal dendritic cell dynamics before and after anti-inflammatory and immunosuppressant eye drops are topically applied into the eye of healthy individuals.
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Participants must satisfy the following conditions prior to inclusion in the study:
- •A)Aged at least 18 years
- •B)Good ocular health
- •C)Willing and able to comply with protocol (e.g. attend study visit)
- •D)Existing wearers should discontinue lens wear for at least 24 hours prior to examination.
- •E)Participants without dry eye will be included.
- •F)Former contact lens wearers will be included
排除标准
- •Any of the following will render a participant ineligible for inclusion:
- •A)Current pregnancy, breastfeeding or traying to become pregnant
- •B)History of ocular trauma or surgery such as LASIK or PRK
- •C)Current or long-term use of topical ocular medication
- •D)Ocular disease or systemic disease that may affect the cornea or conjunctiva (epithelial defects, ulcers and corneal epithelial or basement membrane dystrophies).
- •E)Use of orthokeratology contact lenses within the past 3 months
- •G)Use of soft contact lenses in either eye within 1 month of the study or rigid gas permeable contact lenses within 3 months of the study
- •H)Dry eye disease (defined as defined as a 5-Item dry eye questionnaire (DEQ-5) score equal to 7.
- •AND failing at least one of the objective dry eye tests Non-Invasive Break-Up Time with less than or equal to 10s, or Corneal Fluorescein Staining with greater than or equal to 5 corneal spots.
- •(Note: both eyes will be assessed, and the worst eye will contribute toward the dry eye diagnosis)
- •H) Allergy to fluorometholone, lifitegrast or any of the excipients of the study drugs
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