Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Overall Vision Satisfaction
研究概览
简要总结
The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.
详细描述
Participants were randomized to wear each study contact lenses for 10 days with investigator and participant masking. The participants who are not contact lens wearer at enrollment wore single vision contact lenses for two weeks during the pre-investigation phase to get adapted to contact lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 10 to 16 years;
- •Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC
- •Best corrected visual acuity of at least 20/25 in each eye.
- •Parents/guardians and participant have read and understood the Participant Information Sheet;
- •Parents/guardians and participant have read, signed and dated the Informed Consent;
- •Have normal eyes with the exception of the need for visual correction;
- •Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.
排除标准
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- •Monocular participants (only one eye with functional vision) or participants fit with only one lens;
- •Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
- •History of herpetic keratitis, ocular surgery or irregular cornea;
- •Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
研究组 & 干预措施
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A control lens (Device)
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A test lens 1 (Device)
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A test lens 2 (Device)
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A control lens (Device)
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A test lens 1 (Device)
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A test lens 2 (Device)
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A control lens (Device)
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A test lens 1 (Device)
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2
Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
干预措施: omafilcon A test lens 2 (Device)
结局指标
主要结局
Overall Vision Satisfaction
时间窗: 10 days
Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Habitual Daily Wearing Time
时间窗: 10 days
Habitual daily wearing time in hours
次要结局
- Visual Acuity(10 days)
- Overall Visual Satisfaction During the Use of iPad With White Screen(10 days)
- Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.(10 Days)
- Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.(10 Days)
- Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.(10 Days)