NCT05933772已完成不适用
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Lens Handling on Removal
研究概览
简要总结
The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
详细描述
This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is between 18 and 39 years of age (inclusive) 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, 6 days a week;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears of toric soft contact lenses binocularly.
- •No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
- •the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:
- •i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
- •ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
- •iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
- •iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
- •v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
- •vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
- •vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
- •Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
- •Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
- •Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters
排除标准
- •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
Lens Handling on Removal
时间窗: At the end of one month of wear
Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy).
次要结局
- Distance Visual Acuity(At the end of one month of wear)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
不适用
Clinical Performance of Two Reusable Silicone Hydrogel Contact LensesRefractive ErrorsNCT05431478Alcon Research68
已完成
不适用
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact LensesVision DisordersNCT02595502Johnson & Johnson Vision Care, Inc.286
已完成
不适用
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact LensesMyopiaNCT01966770Coopervision, Inc.20
已完成
不适用
The Clinical Performance of Two Reusable Silicone Hydrogel Contact LensesRefractive AmetropiaNCT05766787Alcon Research190
已完成
不适用
Clinical Evaluation of Two Silicone Hydrogel Contact LensesMyopiaNCT05313412Coopervision, Inc.38