A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Soft Contact Lens When Worn on a 7-Day Extended Wear Basis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 816
- 试验地点
- 2
- 主要终点
- High Contrast Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.
详细描述
Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US.
At the Screening/Dispensing Visit, approximately one-half of the participants will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision soft contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to maintain a monthly replacement schedule. Participants will also be required to complete a paper diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- •Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
- •Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
- •Participants must have clear central corneas and be free of any anterior segment disorders.
- •Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.
排除标准
- •Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •Participants with an active ocular disease or who are using any ocular medication.
- •Participants with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
- •Participants who currently wear monovision, multifocal, or toric contact lenses.
结局指标
主要结局
High Contrast Visual Acuity
时间窗: Month 12
For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).
Number of Participants With Adverse Events
时间窗: Baseline up to Month 12
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.
次要结局
未报告次要终点