NCT01583868已完成不适用
A Study to Evaluate the Product Feasibility of Two New Silicone Hydrogel Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- •Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye.
- •Must agree to wear the study lenses on a daily wear basis for the duration of the study.
- •Must be willing to use a lens care system on a regular basis.
- •If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.
排除标准
- •Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- •Have an active ocular disease, any corneal infiltrative response or are using any ocular medications.
- •Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
- •Any scar or neovascularization within the central 4mm of the cornea.
- •Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Anisometropia (spherical equivalent) of greater than 2.00 D.
- •Any systemic disease affecting ocular health.
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Amblyopic.
- •Allergic to any component in the study products.
- •Have had any corneal surgery (ie, refractive surgery).
- •Currently wear monovision correction, multifocal, or toric contact lenses.
- •Ocular astigmatism greater than 1.00 D in either eye.
结局指标
主要结局
Visual Acuity
时间窗: At 1 week follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
次要结局
- Symptoms and Complaints(At 1 Week follow up)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of a New Silicone Hydrogel Contact LensMyopiaNCT01309880Bausch & Lomb Incorporated66
已完成
不适用
Product Feasibility of a New Silicone Hydrogel Contact LensMyopiaNCT01309100Bausch & Lomb Incorporated144
已完成
不适用
Evaluation of the Feasibility a New Silicone Hydrogel Contact LensMyopiaNCT01309906Bausch & Lomb Incorporated66
已完成
不适用
A Study to Evaluate a New Silicone Hydrogel Contact LensMyopiaNCT01309893Bausch & Lomb Incorporated66
已完成
不适用
A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact LensMyopiaNCT01412983Bausch & Lomb Incorporated100