Characterizing Successful Myopic Multifocal Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Quest Questionnaire Classification Summary
研究概览
简要总结
This will be a prospective, single group, single-arm, and bilateral dispensing study. Subjects will be assigned to a single study lens type to be worn bilaterally in daily wear, and daily disposable modality, for at least 6 hours per day every day for approximately 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential Subjects must satisfy all of the following criteria to be enrolled in the study:
- •The participant must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to volunteer.
- •Had a self-reported eye examination in the last two years.
- •The subject must either already be wearing a presbyopic correction (e.g., reading spectacles over contact lenses, or multifocal spectacles, etc.) or respond positively to at least one symptom on the 'Presbyopic Symptoms Questionnaire".
- •Can achieve best corrected distance monocular visual acuity of at least +0.20 logMAR and binocular visual acuity of at least +0.10 logMAR with refraction.
- •Have a refractive cylinder of ≤1.00 D in each eye.
- •Has corrected best sphere equivalent distance refraction in the range -0.50 D of -6.00 D in each eye (vertex corrected if greater than -4.00D).
- •Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye.
- •Have a wearable pair of spectacles (at the discretion of the investigator) to wear when they cannot wear the study lenses.
排除标准
- •Potential Subjects who meet any of the following criteria will be excluded from participating in the study:
- •Participation in any contact lens or lens care clinical trial within 1 week prior to study enrollment.
- •Employee or immediate family member of an employee of the Centre for Ocular Research & Education listed on the study Delegation Log (e.g., Investigator, Coordinator, Technician).
- •Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of enrollment.
- •Has any known active ocular disease and/or allergies, ocular infections or other abnormalities that are known to interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or corneal distortion.
- •Is using any topical ocular medications other than lubricating eye drops.
- •Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease.
- •Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the discretion of the investigator). This may include, but not be limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
- •Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear film e.g., rheumatoid arthritis, diabetes.
- •Had a change within the previous 3 months to the dosage of a systemic medication known to affect ocular prescription or ocular surface or tear film (e.g., steroids) that in the opinion of the investigator may affect a study outcome variable.
- •Has undergone cataract or refractive error surgery (e.g., radial keratotomy, PRK, LASIK, etc.), or has any planned (during the study) major surgery (e.g. hip replacement), or any planned ocular surgery (e.g. cataract or refractive error surgery).
- •Is a current rigid contact lens wearer, or is wearing contact lenses on extended wear basis, or has a history of extended wear in the past 6 months.
- •Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs.
- •Has a constant unilateral strabismus at both far and near distances, or has anisometropia >2 D between both eyes, or has amblyopia.
- •Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study (Refresh Plus® rewetting drop solution, Sodium Fluorescein or Alcon Clear Care Cleaning System).
- •Has any Grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the biomicroscopy classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear (at the discretion of the investigator).
结局指标
主要结局
Quest Questionnaire Classification Summary
时间窗: Baseline
Subjects are classified into 1 of 4 mutually exclusive groups based on their responses to 6 individual items. 5 items were assessed using the 7-point like-rt scale. A composite score "Life Satisfaction" was calculated for each subject by summing their responses, the final score ranges 0-35 points. Where higher scores indicate higher satisfaction with life. The final item was assessed using a 5 point like-rt scale. If a subject scored 26 or higher for the composite score and responded positively (4 or 5) to the final item, then a subject was classified as "Content \& Driven". If a subject scored 26 or higher but did not respond positively, then "Content \& Indifferent". If a subject scored lower than 26 and responded positively, then "Discontented \& Driven". Lastly, if a subject scored lower than 26 but did not respond positively, then "Discontented \& Indifferent". The percentage of subjects for each group was reported.
Proportion of Successful Lens Wearers
时间窗: 12-Week Follow-up
Successful lens wearers were defined as subjects that fit the following criteria: 1.Completed all required study visits, 2. responded Excellent or Very Good to both the individual questionnaire items (Overall quality of vision and Overall Comfort) and 3. the investigator would recommend the study lenses. Overall quality of Vision and Overall Comfort are individual questionnaire items with the response set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Investigator recommendation was determined by the individual item "In your opinion, is it suitable to prescribe contact lenses for this subject? (Yes/No)". The proportion of successful lens wearers was reported.
次要结局
- Monocular Contrast Threshold(Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up)
- Binocular Contrast Threshold(Baseline, Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up)
- Photopic Pupillometry(Baseline, 1-Week Follow-up)
- Scotopic Pupillometry(Baseline, 1-Week Follow-up)
- Near Stereopsis Threshold(Baseline, 10-mintue Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up)
- Blur Tolerance(Baseline)
- Fixation Disparity With Refraction(Baseline)
- Non-invasive Tear Break-up Time(Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up)
- Coma(Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up)
- Higher Order Aberration(Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up)
- Keratometry (Diopters)(Baseline)
- Keratometry (Degrees)(Baseline)
- Objective Accommodation With Distance Refraction(Baseline, 10-minute Post Lens Fitting, 2-Week Follow-up, 12-Week Follow-up)
- Binocular Visual Acuity (logMAR)(10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up)
- Monocular Visual Acuity (logMAR)(10-minute Post Lens Fitting, 1-Week Follow-up, 2-Week Follow-up, 6-Week Follow-up, 12-Week Follow-up)