Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Subjective Rating For Handling - Insertion
研究概览
简要总结
The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.
详细描述
Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- •Currently wears soft contact lenses.
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination
排除标准
- •Has never worn contact lenses before.
- •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.
结局指标
主要结局
Subjective Rating For Handling - Insertion
时间窗: 1 min
Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
Subjective Rating For Handling - Removal
时间窗: 1 min
Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
General Lens Fit - Fit Acceptance
时间窗: 15min & 6hrs
Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Anterior Ocular Health - Corneal Staining (Central)
时间窗: baseline & 6hrs
Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Lens Surface Assessment of Study Lenses - Surface Wettability
时间窗: 15min & 6hrs
Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
Lens Surface Assessment of Study Lenses - Deposits
时间窗: 15min & 6hrs
Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film \> 75% of surface)
Investigator's Assessment of Stability
时间窗: 15min & 6hrs
Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
Lens Fitting - Rotation/Mislocation
时间窗: Baseline, 15min & 6hrs
Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
Lens Surface Assessment of Study Lenses - Surface Acceptance
时间窗: 15min & 6hrs
Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
Subjective Rating For Comfort - Comfort Since Last Visit
时间窗: 15min, 3hrs, 6hrs
Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
Anterior Ocular Health - Corneal Staining (Nasal)
时间窗: baseline & 6hrs
Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Corneal Staining (Temporal)
时间窗: baseline & 6hrs
Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Subjective Rating For Comfort Preference
时间窗: 1min, 15min, 3hrs, 6hrs
Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Anterior Ocular Health - CornealStaining (Superior)
时间窗: baseline & 6hrs
Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Conjunctival Staining (Inferior)
时间窗: baseline & 6hrs
Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Corneal Staining (Inferior)
时间窗: baseline & 6hrs
Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= \>45% of area)
Anterior Ocular Health - Conjunctival Staining (Nasal)
时间窗: baseline & 6hrs
Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Superior)
时间窗: baseline & 6hrs
Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Temporal)
时间窗: baseline & 6hrs
Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
次要结局
未报告次要终点