Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor) of Color Soft Contact Lenses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Comfort
研究概览
简要总结
Comparative Study to Evaluate the Cosmetic Appearance of Two Brands (Coopervision (CVI) vs. Competitor)of Color Soft Contact Lenses
详细描述
Each lens pair comparison will require two visits over two days, as follows: Visits: V1 (lens dispensing), V2 (20 minutes post lens settling). Each subject will be randomized to wear the test and control lenses in a series of four short fitting comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Is between 18 and 40 years of age (inclusive).
- •Has had a self-reported visual exam in the last two years.
- •Is an adapted wearer of spherical soft contact lenses.
- •Has a contact lens spherical prescription between - 1.00 and - 10.00 (inclusive).
- •Has a spectacle cylinder up to 0.75 diopter (D) in each eye
- •Can achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- •Has clear corneas and no active ocular disease.
- •Has read, understood and signed the information consent letter.
- •Is willing to wear his/hers spectacles over the study contact lenses.
- •Is willing to comply with the wear schedule.
- •Is willing to comply with the visit schedule.
排除标准
- •Has never worn contact lenses before.
- •Currently wears rigid gas permeable contact lenses.
- •Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
- •Has a contact lens prescription outside the range of - 1.00 to -10.00D.
- •Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- •Does not have a pair of corrective spectacles at the time of the visit.
- •Cannot achieve best corrected spectacle distance visual acuity of 20/30 (0.18 logMAR) or better in each eye.
- •Presence of clinically significant (grade > 2.0, scale 0-4) anterior segment abnormalities.
- •Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •Pterygium, pinguecula, or corneal scars within the visual axis
- •Neovascularization > 0.75 mm in from of the limbus
- •Giant papillary conjunctivitis (GCP) worse than grade 1
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, Seborrheic conjunctivitis
- •History of corneal ulcers or fungal infections
- •Poor personal hygiene
- •Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Has aphakia, keratoconus or a highly irregular cornea.
- •Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
结局指标
主要结局
Comfort
时间窗: 20 minutes
Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).
Comfort Preference
时间窗: 20 minutes
Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference
Cosmetic Appearance Preference
时间窗: 20 minutes
Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference
次要结局
未报告次要终点