NCT00349063已完成4 期
The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- To investigate the impact of wearing time and contact lens care solutions on in
研究概览
简要总结
The purpose of this study is to compare the wettability of contact lenses disinfected with three marketed contact lens care solutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had an oculo-visual examination in the last two years.
- •Is at least 18 years old and has full legal capacity to volunteer or is at least 16 years old, has a parent or guardian's permission to participate in the study and has read the Information and Consent Letter for adolescents.
- •Has read and understood the Information Consent Letter (Appendix II).
- •Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- •Has a refractive error that is correctable with the prescription of the available study lenses.
- •Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.
- •Has acceptable fit with the study lenses.
- •Has clear corneas, and ocular clinical findings are considered "normal".
排除标准
- •Has any systemic disease that may affect ocular health.
- •Is using any systemic or topical medications that may affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
- •Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
- •Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
- •Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable.
- •Has refractive astigmatism of more than 0.75 D.
- •Has corneal distortion resulting from rigid lens wear.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of clinical or research study.
- •Is pregnant or lactating.
结局指标
主要结局
To investigate the impact of wearing time and contact lens care solutions on in
vivo and ex vivo wettability of currently marketed contact lenses
次要结局
- To determine if there is a correlation between in vivo wettability, ex vivo
- wettability and in-eye comfort. To determine if comfort and wettability vary
- between symptomatic and asymptomatic lens wearers.
研究者
研究点 (2)
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