A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
研究概览
简要总结
The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- •Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
- •Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
- •Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
- •Subjects must habitually wear soft contact lens.
- •Subject must have no active ocular disease or allergic conjunctivitis.
- •Subject must not be using any topical ocular medications.
- •Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
- •Subjects must habitually use a lens care product for cleaning, disinfection, and storage.
排除标准
- •Subjects 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.
- •Subjects 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.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with an active ocular disease or who are using any ocular medication.
- •Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- •Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
- •Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
- •Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
- •Subjects with any Grade 2 or greater finding during the slit lamp examination.
- •Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- •Subjects who are aphakic.
- •Subjects who are amblyopic.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who are allergic to any component in the study care products.
- •Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.
结局指标
主要结局
Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?
时间窗: 7 days
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses
Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.
时间窗: 7 days
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses
Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.
时间窗: 7 days
Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses
次要结局
- Lens Performance Assessment(2 weeks)
- Any Graded Slit Lamp Finding > 2(2 weeks)