A Comparison of Silicone Hydrogel Lenses: Colored Versus Non-Colored
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- Percentage of Subjects With Same Fit in Both Eyes
研究概览
简要总结
The purpose of this study was to compare the overall fit of AIR OPTIX® COLORS to AIR OPTIX® AQUA contact lenses.
详细描述
Eligible participants were randomized at Visit 1 (Screening) to receive 1 of the 2 investigational products (1:1 assignment). Between Visit 1 and Visit 2, participants wore their habitual AIR OPTIX® AQUA lenses. Investigational products were dispensed at Visit 2 (Baseline), after which participants were asked to return for 2 additional visits: Visit 3 (Day 14) and Visit 4 (Day 28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity ≥ 20/25 in each eye.
- •Manifest cylinder less than or equal to 0.75 diopter (D) (within the previous year) in each eye.
- •Successful wear of AIR OPTIX® AQUA soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
- •Willing to sign an Informed Consent form. If under legal age of consent, legally authorized representative must also sign an Informed Consent form.
- •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 (OTC) or prescribed topical ocular medications within 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 that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.
- •Ocular or intra-ocular surgery within the previous 12 months (excluding placement of punctal plugs).
- •Use of medications contributing to dry eye or ocular irritation unless on a stable dosing regimen for a minimum of 30 days prior to study entry and able to remain on stable regimen throughout the study.
- •Participation in any investigational clinical study within previous 30 days.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Percentage of Subjects With Same Fit in Both Eyes
时间窗: Up to Day 28
Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. "Same fit" was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit.
次要结局
- Subjective Rating of Overall Comfort(Up to Day 28)