Clinical Evaluation of Biomedics 1 Day Toric and MyDay Toric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Subjective Handling at Insertion, Dispensing Visit
研究概览
简要总结
This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.
详细描述
This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear each.
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)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person was eligible for inclusion in the study if he/she:
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and signed an information consent letter.
- •Self-reports having a full eye examination in the previous two years.
- •Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
- •Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
- •Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes.
- •Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- •Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- •Has clear corneas and no active ocular disease.
- •Has read, understood, and signed the information consent letter.
排除标准
- •A person was excluded from the study if he/she:
- •Is participating in any concurrent clinical or research study.
- •Has any known active ocular disease and/or infection that contraindicates contact lens wear.
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
- •Has known sensitivity to the diagnostic sodium fluorescein used in the study.
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
- •Has undergone refractive error surgery or intraocular surgery.
结局指标
主要结局
Subjective Handling at Insertion, Dispensing Visit
时间窗: 15 minutes
Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Subjecting Handling at Insertion, Follow-up Visit
时间窗: 15 minutes
Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
次要结局
未报告次要终点