NCT06305663招募中不适用
A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 418
- 试验地点
- 11
- 主要终点
- Mean change from baseline in axial length.
研究概览
简要总结
A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
详细描述
A Multi-center, Randomized, Parallel, Bilateral, Investigator-masked study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children
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, Outcomes Assessor)
盲法说明
The identity of the study eye will be masked to subjects, assessors, and other masked personnel while masking is maintained..
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian Informed Consent are signed and have capacity to provide voluntary informed consent.
- •Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening:
- •Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive.
- •Astigmatism: ≤ -0.75 D. c. Anisometropia: < 1.00 D.
- •Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye.
- •Subject must have distance best-spectacle corrected visual acuity (BSCVA) by non-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) or better in each eye.
- •Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment.
- •Subject agrees to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 24-month study.
- •Subject must have wearable and visually functioning eyeglasses.
- •Subject must be in good general health according to their and parent's or guardian's knowledge
排除标准
- •Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses.
- •Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment.
- •Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear).
- •Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth.
- •Prior strabismus, intraocular, or refractive surgery.
- •Subject using any systemic or local eye medication that interfere with the wearing of corneal contact lenses, pupil size, adjustment or refractive status, or require the removal of lenses during the day".
- •A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate.
- •A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.
- •Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
- •Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, or diabetes.
- •At the discretion of the Investigator, any ocular, systemic or neuro developmental conditions that could influence refractive development such as, but not limited to: persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring, ptosis, eyelid hemangiomas, Marfan's syndrome, Down syndrome, Ehlers-Danlos syndrome, Stickler syndrome, ocular albinism, retinopathy of prematurity. Subjects with trichiasis, that in the Investigator's judgement does not interfere with contact lens wear, are eligible for this study.
- •Keratoconus or an irregular cornea.
- •Subjects with any Grade 2 or greater finding during the slit lamp examination, or subjects with any scar or neovascularization within the central 6 mm of the cornea, or subjects with corneal infiltrates, of ANY GRADE.
- •Subjects with any "present" finding during the slit lamp examination (biomicroscopy) that, in the investigator's judgment, interferes with contact lens wear. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment does not interfere with contact lens wear, are eligible for this study.
- •The Investigator for any reason considers that it is not in the best interest of the Subject to participate in the study.
- •Subjects participating in any drug clinical investigation within 4 weeks or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or planning to do so during the period of study participation.
- •Immediate family or close relative is a member of site study team members
结局指标
主要结局
Mean change from baseline in axial length.
时间窗: 1 and 2 years
Mean change from baseline in axial length will be evaluated at the one-year and two-year visits.
Mean change from baseline in cycloplegic SERE.
时间窗: 1 and 2 years
Mean change from baseline in cycloplegic SERE will be evaluated at the one-year and two-year visits.
次要结局
未报告次要终点
研究者
研究点 (11)
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