Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Prescription Equivalence
研究概览
简要总结
The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be between 18 and 40 years old.
- •The subject must have normal eyes.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
- •The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
- •The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
- •The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
- •The subject must be an adapted wearer of soft toric contact lenses in both eyes.
- •The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
- •Subjects must already possess a wearable pair of spectacles. -
排除标准
- •Ocular or systemic allergies or disease that may interfere with contact lens wear.
- •Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
- •Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
- •Clinically significant tarsal abnormalities that might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Pregnancy or lactation
- •Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •Strabismus -
研究组 & 干预措施
etafilcon A toric new lens/etafilcon A toric lens
The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
干预措施: etafilcon A toric contact lens with new wetting agent (Device)
etafilcon A toric new lens/etafilcon A toric lens
The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
干预措施: etafilcon A toric contact lens (Device)
etafilcon A toric lens/etafilcon A toric new lens
The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
干预措施: etafilcon A toric contact lens with new wetting agent (Device)
etafilcon A toric lens/etafilcon A toric new lens
The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
干预措施: etafilcon A toric contact lens (Device)
结局指标
主要结局
Prescription Equivalence
时间窗: after 15 minutes of lens wear
Number of subjects whose prescription is the same for the two lenses tested.
次要结局
未报告次要终点