NCT00769665已完成不适用
A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Adverse Events and Visual Acuity
研究概览
简要总结
To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be between 18 and 65 years of age.
- •Provide written Informed Consent.
- •Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens
- •Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
- •Sodium fluorescein (NaFl) corneal staining score sum of < 2 in both eyes (NEI scoring system).
- •Must be willing to maintain pre-enrollment systemic medication regimens during the study.
- •Must be available for study visits and to fill out study questionnaires.
排除标准
- •Has modified their systemic medications within 30 days prior to enrollment.
- •Has a history of allergy to any study product ingredients
- •Is unwilling or unable to meet the study visit timeline.
- •Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
- •Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).
结局指标
主要结局
Adverse Events and Visual Acuity
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
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