Controlling Myopia Progression With Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Spherical Equivalent Refraction
研究概览
简要总结
This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
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
- Single (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
- 否
入选标准
- •The subject must be between 8 and 12 years of age and of Asia origin.
- •The subject's best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
- •Astigmatism must be less than or equal to 1.00D
- •Less than 1.00D difference in spherical equivalent between the two eyes
- •The subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes
- •The subject must have at least 8D of accommodation.
- •The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form
- •The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol
排除标准
- •Ocular or systemic allergies or diseases that may interfere with contact lens wear
- •Systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
- •Anismetropia.
- •Astigmatism of greater than 1.00D in either eye.
- •Eye injury or eye surgery within eight weeks immediately prior to enrollment for this study.
- •Previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye
- •Strabismus in either eye
- •Pupil or lid abnormality or infection in either eye
- •Central corneal scar and aphakia in either eye
- •Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear
- •History of participation in clinical trials aimed to control myopia progression
- •Surgically altered eyes, ocular infection of any type, ocular inflammation
- •Subject has anterior chamber angle grade 2 or narrower
研究组 & 干预措施
Test Soft Contact Lens B
Lenses will be worn in a daily disposable modality
干预措施: Test Soft Contact Lens B (Device)
Test Soft Contact Lens C
Lenses will be worn in a daily disposable modality
干预措施: Test Soft Contact Lens C (Device)
Spectacle Lenses
Control spectacle lenses worn daily.
干预措施: Active Comparator (Device)
结局指标
主要结局
Spherical Equivalent Refraction
时间窗: Baseline and every 6 months post-baseline up to 3 years
Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.
Axial Length (Axial Elongation)
时间窗: Baseline and every 6 months post-baseline up to 3 years
Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.
次要结局
未报告次要终点