A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 主要终点
- Subjective Rating of Overall Comfort
研究概览
简要总结
The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.
- •Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.
- •Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.
- •Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.
- •History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.
- •Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).
- •Monovision, monocular (only one eye with functional vision) or fit with only one lens.
- •History of intolerance or hypersensitivity to any component of the test articles.
- •Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).
- •Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.
- •Current or history of ocular infection, severe inflammation, or disease within previous 6 months.
- •Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
- •Participation in any investigational clinical study within previous 30 days.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AIR OPTIX® COLORS
Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
干预措施: Lotrafilcon B contact lens with color (Device)
FRESHLOOK® COLORBLENDS
Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
干预措施: Phemfilcon A contact lens with color (Device)
结局指标
主要结局
Subjective Rating of Overall Comfort
时间窗: Up to Day 28
Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.
次要结局
- Subjective Rating of Overall Vision(Up to Day 28)
- Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)(Day 28)