DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 主要终点
- Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
研究概览
简要总结
The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent document;
- •Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
- •Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
- •Requires lenses within the power range of study lenses to be fitted;
- •Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;
- •Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
- •Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- •Monocular (only one eye functional) or fit with only 1 lens;
- •Fitted with monovision;
- •Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Currently wearing DT1 MF contact lenses;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DT1 MF, then Habitual
Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
干预措施: Delefilcon A multifocal contact lenses (Device)
DT1 MF, then Habitual
Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
干预措施: Habitual multifocal contact lenses (Device)
Habitual, then DT1 MF
Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
干预措施: Delefilcon A multifocal contact lenses (Device)
Habitual, then DT1 MF
Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
干预措施: Habitual multifocal contact lenses (Device)
结局指标
主要结局
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
时间窗: Day 14, each product
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.
次要结局
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score(Day 14, each product)