Comparing Clariti Elite Versus Proclear 1 Day
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Lens Handling at Insertion
研究概览
简要总结
The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
详细描述
This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Were 17 to 40 years of age and have full legal capacity to volunteer;
- •Had read and signed an information consent letter;
- •Were willing and able to follow instructions and maintain the appointment schedule;
- •Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye
- •Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction;
- •Had an astigmatism of ≤ 0.75DC in subjective refraction;
- •Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit.
- •Demonstrated an acceptable fit with the study lenses.
排除标准
- •Had taken part in another clinical research study within the last 14 days;
- •Were currently habitual wearers of toric, multifocal or monovision lenses.
- •Had worn any rigid contact lenses in the past 6 months
- •Were an extended lens wearer (i.e., sleeping with their lenses)
- •Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes;
- •Had amblyopia and/or distance strabismus/binocular vision problem;
- •Had any known active ocular disease, allergies and/or infection;
- •Had a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Had undergone refractive error surgery or intraocular surgery;
- •Were a member of CORE directly involved in the study.
研究组 & 干预措施
Control Lens, then Test Lens
Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes.
干预措施: Control Lens (Device)
Control Lens, then Test Lens
Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes.
干预措施: Test Lens (Device)
Test Lens, then Control Lens
Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes.
干预措施: Control Lens (Device)
Test Lens, then Control Lens
Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes.
干预措施: Test Lens (Device)
结局指标
主要结局
Lens Handling at Insertion
时间窗: Immediately after lens application
Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.
次要结局
未报告次要终点