Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
研究概览
简要总结
The aim of this fitting study is to evaluate the clinical performance of different hydrogel and silicone hydrogel contact lenses.
详细描述
This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 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 contact lens wearer
- •Has a cl spherical prescription between -1.00 and -6.00 (inclusive)
- •Has a spectacle cylinder up to 0.75D (diopter) in each eye
- •Is correctable to a visual acuity of 20/25 or better in both eyes
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the information consent letter
- •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 contact lens wear (5 days per week; > 8 hours/day)
- •Has a contact lens prescription outside the range of -1.00 to -6.00D
- •Has a spectacle cylinder ≥ 1.00D of cylinder in either eye
- •Has best corrected spectacle distance vision worse than 20/25 in either eye
- •Has any systemic or topical medications that will affect ocular health
- •Has any ocular pathology or severe insufficiency of lacrimal secretion
- •Has persistent, clinically significant corneal or conjunctival staining
- •Has active neovascularization or any central corneal scars
- •Is aphakic
- •Is presbyopic
- •Has undergone corneal refractive surgery
- •Is participating in any other type of eye related conical or research study
结局指标
主要结局
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)
时间窗: Day 1 - Insertion
Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
时间窗: Day 1 - 30 minutes
Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Contact Lens Insertion (Day 2 Study Lenses)
时间窗: Day 2 - Insertion
Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)
时间窗: Day 2 - Insertion
Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)
时间窗: Baseline
Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)
时间窗: Day 2 - 30 minutes
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)
Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)
时间窗: Day 2 - 30 minutes
Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever
Comfort Contact Lens Insertion (Day 1 Study Lenses)
时间窗: Day 1 - Insertion
Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
时间窗: Day 1 - 30 minutes
Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
时间窗: Day 1 - 30 minutes
Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
时间窗: Day 2 - 30 minutes
Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)
Visual Acuity (VA) logMAR (Study Lenses)
时间窗: Dispense
Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)
时间窗: Day 1 - Insertion
Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)
时间窗: Day 2 - Insertion
Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)
时间窗: Day 2 - Insertion
Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
时间窗: Day 2 - 30 minutes
Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)
Lens Fitting Characteristics, Centration (Day 1 Study Lenses)
时间窗: Day 1 - 30 minutes
Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Lens Fitting Characteristics, Centration (Day 2 Study Lenses)
时间窗: Day 2 - 30 minutes
Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Visual Acuity (VA) logMAR (Habitual Lenses)
时间窗: Baseline
Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)
Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
时间窗: Day 2 - 30 minutes
Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Lens Fitting Characteristics, Tightness (Habitual Lens)
时间窗: Baseline
Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)
时间窗: Day 1 - 30 minutes
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)
时间窗: Day 2 - Insertion
Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)
时间窗: Day 1 - 30 minutes
Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)
Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)
时间窗: Day 1 Insertion
Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)
Lens Fitting Characteristics, Centration (Habitual Lens)
时间窗: Baseline
Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)
Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)
时间窗: Day 1 - 30 minutes
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)
时间窗: Day 2 - 30 minutes
Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)
时间窗: Day 1- 30 minutes
Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)
时间窗: Day 1- 30 minutes
Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)
时间窗: Day 1 - 30 minutes
Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Overall Ease of Lens Handling (Day 2 Study Lenses)
时间窗: Day 2 - After Removal
Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy
Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)
时间窗: Day 2 - Insertion
Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
Overall Ease of Lens Handling (Day 1 Study Lenses)
时间窗: Day 1 - After Removal
Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy
Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)
时间窗: Day 2 - Insertion
Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)
次要结局
未报告次要终点