AIR OPTIX® COLORS Registration Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
研究概览
简要总结
The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.
详细描述
This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- •Normal eyes and not using any ocular medications.
- •Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
- •Manifest cylinder less than or equal to 0.75 diopter.
- •Best spectacle corrected visual acuity greater than or equal to 20/
- •Have current prescription glasses.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Anterior segment infection, inflammation, or abnormality.
- •Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
- •Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- •History of refractive surgery or irregular cornea.
- •History of pathologically dry eye.
- •Corneal vascularization greater than 1 millimeter of penetration.
- •History of herpetic keratitis.
- •Eye injury within 12 weeks immediately prior to enrollment in this trial.
- •Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)
时间窗: Up to Month 3
Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.
次要结局
- Subjective Rating of Overall Vision(Up to Month 3)
- Subjective Rating of Overall Comfort(Up to Month 3)
- Subjective Rating of Overall Handling(Up to Month 3)
- Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)(Up to Month 3)
- Lens Centration (Centered, Slight Decentration)(Up to Month 3)
- Dry Areas/Non-Wetting (None, Very Slight)(Up to Month 3)
- Front Surface Deposits (None, Very Slight)(Up to Month 3)
- Back Surface Deposits (None, Very Slight)(Up to Month 3)