Evaluation of a Lubricant Eye Drop on Tear Lipid Layer Thickness in Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 主要终点
- Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
研究概览
简要总结
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Must sign the informed consent form.
- •Stable, tear lipid layer thickness ≤ 75 nm without contact lenses.
- •Successfully wearing bi-weekly or monthly replacement soft contact lenses in both eyes for a minimum of 5 days/week during the past 2 months prior to Visit
- •Vision correctable to 20/25 Snellen (feet) or better at distance with habitual contact lenses at Visit
- •Willing to wear lenses 5 days a week, 8 hours a day for at least 2 days during the study.
- •Demonstrate symptoms of contact lens discomfort.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Routinely sleeping in lenses.
- •Any active eye inflammation or condition that contraindicates contact lens wear.
- •Any systemic diseases that could prevent successful contact lens wear.
- •Use of systemic or ocular medications that contraindicate lens wear.
- •Fit with only 1 contact lens.
- •Unwilling to discontinue the use of cosmetics (such as eyeliner, mascara, or eye shadow) or facial creams on or around the eyelids on Day 1 and Day 14 of the study.
- •Women of childbearing potential who are currently pregnant, test positive for pregnancy at Screening visit, breast feeding, or unwilling to use adequate birth control throughout the study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FID 114657
FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
干预措施: FID 114657 eye drops (10 ml) (Drug)
FID 114657
FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
干预措施: Habitual contact lenses (Device)
Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
干预措施: Saline control eye drops (15 ml) (Drug)
Saline Control
Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
干预措施: Habitual contact lenses (Device)
结局指标
主要结局
Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1
时间窗: Day 1, after 2 hours of lens wear
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.
次要结局
- Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14(Baseline (Day 0), Day 14)
- Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses(Baseline (Day 0), Day 14)
- Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14(Baseline (Day 0), Day 14)
- Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14(Day 14, after 2 hours of lens wear)