A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vision Quality With Contact Lens Prescription
研究概览
简要总结
The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.
详细描述
Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.
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
- Single (Participant)
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
- •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 toric contact lens wearer
- •Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
- •Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
- •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 (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- •Is willing to comply with the visit schedule
排除标准
- •A person will be excluded from the study if he/she:
- •Has a contact lens prescription outside the range of the available parameters of the study lenses.
- •Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
- •Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
- •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 (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
Vision Quality With Contact Lens Prescription
时间窗: Dispense
Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Visual Acuity logMAR
时间窗: 4 Weeks
Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)
Lens Marking Visibility
时间窗: 4 weeks
Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)
Wavefront Aberrations RMS (3mm)
时间窗: 4 Weeks
Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).
Vision Quality Insertion, During Day, End Day, Night
时间窗: 4 weeks
Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Vision Stability on Insertion, During Day, End Day
时间窗: 4 weeks
Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Overall Sensation of Moistness
时间窗: 4 weeks
Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Comfort Satisfaction
时间窗: 4 weeks
Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Handling Satisfaction
时间窗: 4 weeks
Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Overall Fit Acceptance
时间窗: 4 weeks
Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)
Overall Sensation of Smoothness
时间窗: 4 weeks
Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)
Comfort Upon Contact Lens Insertion
时间窗: Dispense
Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)
Lens Stability 5-10 Min
时间窗: 4 weeks
Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.
Wavefront Aberrations Root Mean Square (RMS) (3mm)
时间窗: 2 Weeks
Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).
Wavefront Aberrations RMS (5mm)
时间窗: 4 Weeks
Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).
Overall Stability
时间窗: 4 weeks
Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.
Daily and Comfortable Wearing Time
时间窗: 4 weeks
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction
时间窗: 4 weeks
Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)
Vision Quality Insertion, During Day, End Day
时间窗: Baseline
Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Vision Stability Insertion, During Day, End Day
时间窗: Baseline
Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)
Dryness Satisfaction
时间窗: 4 weeks
Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Lens Fit Satisfaction
时间窗: 4 weeks
Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Vision Satisfaction Upon Contact Lens Insertion
时间窗: Dispense
Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)
Corneal Coverage
时间窗: 4 weeks
Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)
Lens Orientation Primary Gaze
时间窗: 4 weeks
Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)
Lens Stability on Blink
时间窗: 4 weeks
Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)
Vision Satisfaction
时间窗: 4 weeks
Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Overall Satisfaction
时间窗: 4 weeks
Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)
Vision Stability Upon Contact Lens Insertion
时间窗: Dispense
Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)
Centration
时间窗: 4 weeks
Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)
Post Blink Movement
时间窗: 4 weeks
Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)
Lens Overall Stability
时间窗: Dispense
Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)
Rotational Recovery 30/45 Deg
时间窗: 4 weeks
Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)
Participants Use of Rewetting Drops
时间窗: 4 Weeks
Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)
Lens Surface Deposits
时间窗: 4 weeks
Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)
次要结局
- Corneal Infiltrates(4 weeks)
- Lower Palpebral Hyperaemia(4 weeks)
- Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.(8 weeks)
- Limbal Hyperaemia(4 weeks)
- Corneal Neovascularization(4 weeks)
- Participant Preference for Their Habitual Lenses or Either of the Study Lenses(8 weeks)
- Corneal Stromal Haze(4 weeks)
- Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)(4 weeks)
- Participants Likelihood of Continuing to Wear the Study Lenses.(4 weeks)
- Participant Preference for Either of the Study Lenses(8 weeks)
- Bulbar Hyperaemia(4 weeks)
- Participant Recommendation of a Study Lens to Friends, Family or Colleagues(8 weeks)
- Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)(4 weeks)
- Participants Likelihood of Switching From Habitual Lenses to the Study Lenses(4 weeks)