Dispensing Study for The Phenacite Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Near Visual Acuity (VA) - High Illumination
研究概览
简要总结
This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.
详细描述
This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.
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)
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:
- •Oculo-visual examination in the last two years
- •Between 18 and 35 years of age and has full legal capacity to volunteer
- •Has read and understood the informed 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
- •Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D
- •Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
- •Has not worn lenses for at least 12 hours before the initial visit
- •Has a subjective response at baseline, which indicates suitability for this study
- •Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- •Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before
- •Any systemic disease affecting ocular health
- •Is using any systemic or topical medications that will affect ocular health
- •Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- •Has any ocular pathology or anomaly that would affect the wearing of the lenses
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- •Is aphakic
- •Has anisometropia of >1.00
- •Has undergone corneal refractive surgery
- •Has strabismus
- •Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
- •Is participating in any other type of eye related clinical or research study
- •Has previously participated in study of the Phenacite lenses
研究组 & 干预措施
Phenacite Test lens then comfilcon A control lens
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
干预措施: comfilcon A (Device)
Phenacite Test lens then comfilcon A control lens
Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
干预措施: Phenacite (Device)
Comfilcon A control lens then Phenacite test Lens
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
干预措施: Phenacite (Device)
Comfilcon A control lens then Phenacite test Lens
Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.
干预措施: comfilcon A (Device)
结局指标
主要结局
Near Visual Acuity (VA) - High Illumination
时间窗: 1 week
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination
时间窗: 1 week
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Quality of Intermediate Vision
时间窗: 1 week
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Overall Vision Quality
时间窗: 1 week
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Near Visual Acuity (VA) - Low Illumination
时间窗: 1 week
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Distance Visual Acuity (VA) - High Illumination
时间窗: 1 week
Distance visual acuity High Illumination was assessed using logMAR
Quality of Distance Vision
时间窗: 1 week
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Near Vision
时间窗: 1 week
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Quality of Vision With Digital Device Use
时间窗: 1 week
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Distance Visual Acuity (VA) - High Illumination
时间窗: Baseline (after 10 minutes of lens dispense)
Distance visual acuity High Illumination was assessed using logMAR
Near Visual Acuity (VA) - High Illumination
时间窗: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination
时间窗: Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Near Visual Acuity (VA) - Low Illumination
时间窗: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Quality of Distance Vision
时间窗: Baseline (after 10 minutes of lens dispense)
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Near Vision
时间窗: Baseline (After 10 minutes of lens dispense)
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Quality of Vision With Digital Device Use
时间窗: Baseline (After 10 minutes of lens dispense)
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Intermediate Vision
时间窗: Baseline (After 10 minutes of lens dispense)
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Overall Vision Quality
时间窗: Baseline (After 10 minutes of lens dispense)
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
次要结局
- Overall Comfort(1 week)
- Subjective Questionnaire Response - Vision(1 week)
- Subjective Ratings of Change in Severity of Tiredness(1 week)
- Biomicroscopy Findings- Limbal Hyperemia(1 week)
- Biomicroscopy Findings - Corneal Staining Extent(1 week)
- Overall Dryness(1 week)
- Lens Preference - Overall Vision Preference(1 week)
- Subjective Ratings of Change in Frequency of Tiredness(1 week)
- Ghosting - Distance Vision(1 week)
- Subjective Ratings of Change in Bothersome Rating for Tiredness(1 week)
- Biomicroscopy Findings - Bulbar Hyperemia(1 week)
- Ghosting - Near Vision(1 week)
- Subjective Ratings of Change in Severity of Dryness(1 week)
- Subjective Questionnaire Response - Eye Feel Good(1 week)
- Subjective Questionnaire Response - Eye Tired(1 week)
- Subjective Ratings of Change in Frequency of Dryness(1 week)
- Subjective Questionnaire Response - Eye Strain(1 week)
- Subjective Questionnaire Response - Eye Feel Relaxed(1 week)
- Subjective Ratings of Change in Bothersome Rating of Dryness(1 week)
- Overall Comfort(Baseline (After 10 minutes of lens dispense))
- Overall Dryness(Baseline (after 10 minutes of lens dispense))