NCT00995189已完成不适用
A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Subjective Dryness
研究概览
简要总结
The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.
详细描述
Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reports late-day dryness symptoms with contact lens wear on questionnaire.
- •Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
- •Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Wears daily disposable contact lenses.
- •Has significant symptoms related to lens fit or lens deposits.
- •Requires concurrent ocular medication (rewetting drops allowed).
- •Has used Restasis® in the last 3 months.
- •Wears punctal plugs fitted in the last 30 days.
- •Has any current systemic or ocular abnormality, infection or disease.
- •Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
- •Has a history of refractive surgery.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Subjective Dryness
时间窗: 2 weeks, one month
次要结局
- conjunctival staining(two weeks, one month)
- corneal staining(2 weeks, one month)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens WearersAsthenopiaMyopiaNCT03585790Pete Kollbaum, OD, PhD45
已完成
不适用
Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular SurfaceHealthyNCT00707291University of Miami61
已完成
不适用
Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia ControlMyopiaNCT04709237Coopervision, Inc.21
已完成
不适用
Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens WearersMyopiaNCT00929487Alcon Research278
进行中（未招募）
不适用
Effect of Defocus in Soft Contact Lenses on Internal Retinal VascularizationNearsightednessNCT06527274Université de Montréal25