A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of NNR06 Multi-Purpose Solution cleaning and disinfecting solution (Test) compared to COMPLETE Multi-Purpose Solution cleaning and disinfecting solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately three months.
详细描述
Approximately 398 subjects (796 eyes) will be enrolled in this three-month controlled, parallel group, masked, randomized study at approximately 22 investigative sites in the United States (US). Approximately one-half of the subjects will be randomized to receive Bausch & Lomb investigational NNR06 Multi-Purpose Solution to be used with a rub care regimen (Test), and approximately one-half of the subjects will be randomized to receive COMPLETE Multi-Purpose Solution with a rub care regimen (Control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Is a habitual wearer of one of the following lens types:
- •Lens Group Lens Material Trade Name Manufacturer
- •4 Etafilcon A Acuvue2 Vistakon
- •5-A Balafilcon A PureVision2 Bausch + Lomb
- •5-C Samfilcon A Ultra Bausch + Lomb
- •5-Cm Lotrafilcon B Optix Aqua Alcon
- •5-Cr Senofilcon A Oasys Vistakon
- •Is correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses.
- •Has clear central corneas and is free of any anterior segment disorders.
- •Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses.
- •Requires lens correction in both eyes.
- •Wears the same manufacturer and brand of lens in both eyes.
- •Agrees to wear study lenses on a daily wear basis for approximately three months.
- •Is willing and able to comply with all treatment and follow-up/study procedures.
排除标准
- •Has worn gas permeable (GP) lenses within the last 30 days.
- •Has worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •Has 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.
- •Currently wears monovision, multifocal, or toric contact lenses.
- •Has ocular astigmatism of 1.00D or greater in either eye.
- •Is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses.
- •Has anisometropia (spherical equivalent) of greater than 2.00D
- •Has any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for Methods of Clinical Evaluation).
- •Has corneal infiltrates, of ANY GRADE.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Has any scar or neovascularization within the central 4 mm of the cornea. Note that subjects with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- •Is aphakic.
- •Is amblyopic.
- •Has had any corneal surgery (e.g., refractive surgery).
- •Is allergic to any component in the study care products.
研究组 & 干预措施
Bausch & Lomb (B&L) NNR06 Multi-Purpose Solution (MPS)
B & L investigational NNR06 used as a rub care regimen (Test)
干预措施: NNR06 (Device)
COMPLETE MPS
B&L Multi-Purpose Solution as a rub care regimen (Control)
干预措施: Complete MPS (Device)
结局指标
主要结局
The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.
时间窗: 3 months
A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test - Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).
次要结局
未报告次要终点