Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Vision Quality
研究概览
简要总结
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age and no more than 39 years of age
- •Existing soft contact lens wearers
- •Willing to signed a written Informed Consent.
- •Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
- •Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
- •Have an Astigmatism of 1.00D or less in both eyes.
- •Require a visual correction in both eyes.
- •Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
- •Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.
排除标准
- •Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Clinically significant corneal staining (Grade 3 in more than one region).
- •Keratoconus or other corneal irregularity.
- •Abnormal lachrymal secretions.
- •Extended wear of contact lenses last 3 months.
- •Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
- •Refractive surgery.
- •Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Require concurrent ocular medication
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
- •Diabetes.
- •Pregnant, lactating or planning a pregnancy at the time of enrollment.
- •Participation in any concurrent clinical trial or in last 30 days.
研究组 & 干预措施
etafilcon A/omafilcon A
etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily
干预措施: etafilcon A (Device)
etafilcon A/omafilcon A
etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily
干预措施: omafilcon A (Device)
omafilcon A/etafilcon A
omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.
干预措施: etafilcon A (Device)
omafilcon A/etafilcon A
omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.
干预措施: omafilcon A (Device)
结局指标
主要结局
Vision Quality
时间窗: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Subjective Rating of Handling
时间窗: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Corneal Staining
时间窗: after 1 week of lens wear
Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Limbal Hyperemia
时间窗: after 1 week of wear
This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Subjective Rating of Quality Perceptions
时间窗: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Subjective Rating of Comfort
时间窗: after 1 week of lens wear
This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
次要结局
未报告次要终点