Clinical Validation Study of Phoebe Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Corneal Staining Extent
研究概览
简要总结
The purpose of this study is to validate the clinical performance of a new contact lens design.
详细描述
Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).
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
- Double (Participant, Investigator)
盲法说明
Double masked (participant, investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Between and 18 and 35 years of age and has full legal capacity to volunteer
- •Has had a self-reported oculo-visual examination in the last two years
- •Has read and understood the information consent letter
- •Is willing and able to follow instructions and maintain the appointment schedule
- •Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- •Has a Contact Lens Refraction between -1.00D and -6.00D
- •Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
- •Currently wears soft contact lenses
- •Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
- •Has clear corneas and no active ocular disease
- •Has not worn lenses for at least 12 hours before the first visit
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before
- •Is wearing Monovision modality
- •Has any systemic disease affecting ocular health
- •Is using any systemic or topical medications that will affect ocular health
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars
- •Is aphakic
- •Has undergone corneal refractive surgery
- •Is participating in any other type of eye related clinical or research study
研究组 & 干预措施
Test lens
Subjects randomized to wear pair of test lens either first or second
干预措施: stenfilcon A lens (control) (Device)
stenfilcon A lens (control)
Subjects randomized to wear pair of control lens either first or second
干预措施: Phoebe test lens (Device)
stenfilcon A lens (control)
Subjects randomized to wear pair of control lens either first or second
干预措施: stenfilcon A lens (control) (Device)
Test lens
Subjects randomized to wear pair of test lens either first or second
干预措施: Phoebe test lens (Device)
结局指标
主要结局
Corneal Staining Extent
时间窗: Day 3
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
Palpebral Hyperemia on Upper Lid
时间窗: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
时间窗: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Conjunctival Staining Score
时间窗: Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Lower Lid
时间窗: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
时间窗: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Corneal Staining Extent
时间窗: Baseline
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=\>45% of area).
Conjunctival Staining Score
时间窗: Baseline
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Upper Lid
时间窗: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Lower Lid
时间窗: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
时间窗: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
时间窗: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
次要结局
- Distance Visual Acuity(Day 3)
- Near Visual Acuity(Day 3)
- Vision Quality Rating(Day 3)
- Distance Visual Acuity(Baseline (at lens dispense))
- Near Visual Acuity(Baseline (at dispense))
- Vision Quality Rating(Baseline (at dispense))