NCT06431061已完成不适用
Clinical Evaluation of Proclear Toric and Biofinity Toric
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Overall Fit Acceptance
研究概览
简要总结
The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.
详细描述
The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 17 years of age and has full legal capacity to volunteer.
- •Have understood and signed an information consent letter.
- •Are willing and able to follow instructions and maintain the appointment schedule.
- •Are an adapted soft toric contact lens wearer.
- •Do not habitually wear either of the two study lens types.
- •Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.
- •Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
- •Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.
排除标准
- •Are participating in any concurrent clinical or research study.
- •Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use.
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
- •Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- •Have a history of not achieving comfortable CL use (5 days per week; > 8 hours/day)
- •Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. on the delegation log).
结局指标
主要结局
Overall Fit Acceptance
时间窗: After 15 minutes of continuous wear
Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of Two Toric Soft Contact LensesAstigmatismNCT06490302CooperVision, Inc.40
已完成
不适用
A Clinical Comparison of Two Soft Toric Contact LensesAstigmatismNCT06758089CooperVision International Limited (CVIL)42
已完成
不适用
Clinical Evaluation of Two Toric Contact LensesAstigmatismNCT05688657Coopervision, Inc.42
已完成
不适用
Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens UsersAstigmatismNCT01180998Johnson & Johnson Vision Care, Inc.200
已完成
不适用
A Clinical Comparison of Two Multifocal Toric Soft Contact LensesPresbyopiaAstigmatismNCT06438601CooperVision, Inc.36