NCT01461811已完成不适用
ARES Registration Trial
CIBA VISION0 个研究点目标入组 154 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 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 demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.
详细描述
Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
- •Normal eyes not using any ocular medications that would contraindicate lens wear.
- •Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
- •Spectacle cylinder prescription between 0.50 and 2.00 diopters.
- •Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Anterior segment infection, inflammation, or abnormality.
- •Any active anterior segment or systemic disease that would contraindicate contact lens wear.
- •Use of systemic medications that would contraindicate lens wear.
- •Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
- •History of herpetic keratitis.
- •History of refractive surgery or irregular cornea.
- •History of pathologically dry eye.
- •Corneal vascularization greater than 1 mm of penetration.
- •Eye injury within twelve weeks immediately prior to enrollment in this trial.
- •Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
- •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
- Front Surface Deposits (None, Very Slight)(Up to Month 3)
- Subjective Rating of Insertion Comfort(Up to Month 3)
- Subjective Rating of End of Day Comfort(Up to Month 3)
- Subjective Rating of Overall Comfort(Up to Month 3)
- Subjective Rating of End of Day Dryness(Up to Month 3)
- Subjective Rating of Overall Vision(Up to Month 3)
- Subjective Rating of Overall Handling(Up to Month 3)
- Lens Centration (Centered, Slight Decentration)(Up to Month 3)
- Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)(Up to Month 3)
- Front Surface Wettability (None, Very Slight)(Up to Month 3)
- Back Surface Debris/Deposits (None, Very Slight)(Up to Month 3)
研究者
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