Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Correlation Between Subjective CLUE Comfort and Keratometry
研究概览
简要总结
The objective of this study is to determine if corneal diameter and keratometry readings correlate to subjective comfort and lens fitting characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must be no less than 18 and no more than 45 years of age with no presbyopic add.
- •The subject must be willing and able to adhere to the instructions set out in the protocol.
- •The subject must be an adapted soft contact lens wearer in both eyes.
- •The subject must be willing to wear the study contact lenses up to 14 hours/day.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 Diopters (D) to -6.00 D in each eye.
- •The subject must have refractive cylinder less than or equal to 1.00 D in each eye.
- •The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
- •The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Current 1-DAY ACUVUE® TruEye® wearers
- •Anisometropia of 1.00 D or greater
- •Any Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- •Any Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which 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
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- •Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
结局指标
主要结局
Correlation Between Subjective CLUE Comfort and Keratometry
时间窗: 3-day follow-up
CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter \[DK\]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.
Correlation Between Subjective CLUE Comfort and Corneal Diameter
时间窗: 3-day follow-up
Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter \[HVID\]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.
次要结局
未报告次要终点