MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
- 试验地点
- 60
- 主要终点
- Mean difference in cycloplegic SERE change from baseline
研究概览
简要总结
The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.
详细描述
This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years.
Part 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses.
Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent and Assent have been completed
- •Be between 8 and 12 years of age inclusive at the time of enrollment.
- •Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye
- •Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
- •Anisometropia: ≤ 1.50D SERE.
- •Astigmatism: ≤ 0.75 D
- •Free of ocular disease or abnormalities (including any corneal scar)
- •Currently have good general health.
- •Agree to accept the lens as assigned by the randomization.
- •Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
- •Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes.
- •Able to maintain the visit schedule.
- •Willingness to participate in the trial for 4 years.
- •Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
- •Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.
排除标准
- •Current or prior use of any pharmaceuticals or other methods for control of myopia, such as bifocals, progressive addition lenses, orthokeratology, atropine, pirenzepine or any other myopia control treatment.
- •Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day.
- •Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
- •Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:
- •Acute and subacute inflammation or infection of the anterior chamber of the eye.
- •Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
- •Severe insufficiency of lacrimal secretion (dry eyes).
- •Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
- •Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
- •Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
- •Any active corneal infection (bacterial, fungal, or viral).
- •If eyes are red or irritated.
- •The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
- •Has history of:
- •Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
- •Giant papillary conjunctivitis
- •Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses
- •A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
- •Corneal hypoesthesia (reduced corneal sensitivity)
- •Keratoconus or an irregular cornea.
- •Strabismus or amblyopia.
- •Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
研究组 & 干预措施
MiSight 1 day
MiSight 1 day
干预措施: MiSight 1 Day (Device)
Proclear 1 day
Proclear 1 day
干预措施: Proclear 1 day (Device)
结局指标
主要结局
Mean difference in cycloplegic SERE change from baseline
时间窗: 3 years
Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters
Mean difference in axial length change from baseline
时间窗: 3 years
Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters
Mean difference in rate of cycloplegic SERE change - Part 2 study
时间窗: 1 year
Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment; measured with cycloplegic auto-refraction in Diopters
Mean difference in rate of axial length - Part 2 study
时间窗: 1 year
Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment.
次要结局
- Percentage of subjects with no appreciable myopic progression(3 years)
- Visual symptoms and the effects on activities of daily living(3 years)