Non-dispensing Fitting Study Comparing the Clinical Performance Hydrogel Sphere Design Contact Lenses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Centration - Pair One
研究概览
简要总结
The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
详细描述
This is a 35-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different hydrogel lens materials. For each study, this study will involve 2 visits: lens dispensing (baseline) and 1 hour post lens settling. Each subject will be randomized to wear the test and control lenses, in the right or left eye, in a series of four short fitting comparisons as follows:
Pair 1 (P1): filcon IV I (Base Curve (BC) 8.6) and ocufilcon D
Pair 2 (P2): filcon IV I (Base Curve (BC) 8.7) and ocufilcon D
Pair 3 (P3): methafilcon A (Base Curve (BC) 8.6) and ocufilcon D
Pair 4 (P4): methafilcon A (Base Curve (BC)8.7) and somofilcon A
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
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is between 18 and 40 years of age (inclusive).
- •Has had a self-reported visual exam in the last two years.
- •Is an adapted soft CL (Contact Lens) wearer.
- •Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- •Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
- •Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- •Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- •Has clear corneas and no active ocular disease.
- •Has read, understood and signed the information consent letter.
- •Patient contact lens refraction should fit within the available parameters of the study lenses.
- •Is willing to comply with the wear schedule.
- •Is willing to comply with the visit schedule.
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before.
- •Currently wears rigid gas permeable contact lenses.
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has a CL prescription outside the range of - 1.00 to - 6.00D
- •Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- •Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- •Presence of clinically significant (grade 2-4) 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 (GPC) 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.
研究组 & 干预措施
filcon IV I (BC 8.7) / ocufilcon D (pair two)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: ocufilcon D (Device)
methafilcon A (BC 8.6) / ocufilcon D (pair three)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: ocufilcon D (Device)
filcon IV I (BC 8.6) / ocufilcon D (pair one)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: ocufilcon D (Device)
filcon IV I (BC 8.6) / ocufilcon D (pair one)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: filcon IV I (BC 8.6) (Device)
filcon IV I (BC 8.7) / ocufilcon D (pair two)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: filcon IV I (BC 8.7) (Device)
methafilcon A (BC 8.6) / ocufilcon D (pair three)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: methafilcon A (BC 8.6) (Device)
methafilcon A (BC 8.7) / somofilcon A (pair four)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: methafilcon A (BC 8.7) (Device)
methafilcon A (BC 8.7) / somofilcon A (pair four)
Participants were randomized to a test and control lens for each pair in a contralateral design.
干预措施: somofilcon A (Device)
结局指标
主要结局
Centration - Pair One
时间窗: Baseline and 1 hour
Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Four
时间窗: Baseline and 1 hour
Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Post-blink Movement - Pair Two
时间窗: 1 hour
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three
时间窗: 1 hour
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four
时间窗: 1 hour
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair One
时间窗: 1 hour
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Lens Tightness - Pair Two
时间窗: Baseline and 1 hour
Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Three
时间窗: Baseline and 1 hour
Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair One
时间窗: Baseline and 1 hour
Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Lens Tightness - Pair Four
时间窗: Baseline and 1 hour
Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)
Overall Fit Acceptance - Pair Two
时间窗: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.
Centration - Pair Two
时间窗: Baseline and 1 hour
Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Centration - Pair Three
时间窗: Baseline and 1 hour
Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).
Overall Fit Preference - Pair One
时间窗: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Three
时间窗: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.
Overall Fit Acceptance - Pair Four
时间窗: Baseline and 1 hour
Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.
Post-blink Movement - Pair One
时间窗: Baseline
Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Two
时间窗: Baseline
Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Three
时间窗: Baseline
Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
Post-blink Movement - Pair Four
时间窗: Baseline
Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).
次要结局
未报告次要终点