A Clinical Evaluation of the Causes of Soft Contact Lens Related Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 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.
研究组 & 干预措施
OFR
Opti-Free RepleniSH contact lens care solution used for 30 days
干预措施: Opti-Free RepleniSH (Device)
OFR
Opti-Free RepleniSH contact lens care solution used for 30 days
干预措施: Contact lenses (Device)
RNM
ReNu MultiPlus contact lens care solution used for 30 days
干预措施: ReNu MultiPlus (Device)
RNM
ReNu MultiPlus contact lens care solution used for 30 days
干预措施: Contact lenses (Device)
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)