Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Risk of adverse events
研究概览
简要总结
This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.
详细描述
The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Research optometrists conducting eye examinations and technicians conducting fluorometry measurements did not know whether a given subject was in the treatment (irrigating) or control (non-irrigating) group.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS;
- •less than 0.75 diopters (D) of astigmatism;
- •free of any ocular disease or systemic disease with ocular manifestation;
排除标准
- •history of contact lens wear within the past year;
- •history of ocular surgery or serious injury;
- •presence of corneal scarring;
- •frequent swimming, smoking, or use of medications w/ ocular side effects;
研究组 & 干预措施
30-day SiH CW, No Daily Irrigation
Control group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution
干预措施: 30-day SiH CW (Device)
30-day SiH CW, Daily Irrigation
Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening
干预措施: Daily irrigation (Drug)
30-day SiH CW, Daily Irrigation
Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening
干预措施: 30-day SiH CW (Device)
结局指标
主要结局
Risk of adverse events
时间窗: Post-30-day CW of SiH contact lenses
Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall
Corneal epithelial permeability (Pdc) Post-1-Day CW
时间窗: Post-1-Day CW of SiH contact lenses
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW
Corneal epithelial permeability (Pdc) Post-30-Day CW
时间窗: Post-30-Day CW of SiH contact lenses
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW
Corneal epithelial permeability (Pdc) at Baseline
时间窗: Baseline
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses
次要结局
未报告次要终点
研究者
Meng C. Lin
Associate Professor, Clinical Optometry and Vision Science Program
University of California, Berkeley