Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Monocular Visual Acuity Assessment
研究概览
简要总结
The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
- •The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
- •Any cylinder power must be ≤ -0.75D.
- •The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- •The subject must read and sign the Statement of Informed Consent.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
排除标准
- •Ocular or systemic allergies or disease which might interfere with contact lens wear.
- •Systemic disease or use of medication which might interfere with contact lens wear.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Pregnancy or lactation.
- •Diabetes.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- •Habitual contact lens type is toric, multifocal, or is worn as extended wear.
研究组 & 干预措施
galyfilcon A prototype lens/enfilcon A lens
galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
干预措施: galyfilcon A prototype lens (Device)
galyfilcon A prototype lens/enfilcon A lens
galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
干预措施: enfilcon A lens (Device)
enfilcon A lens/galyfilcon A prototype lens
enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
干预措施: galyfilcon A prototype lens (Device)
enfilcon A lens/galyfilcon A prototype lens
enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
干预措施: enfilcon A lens (Device)
结局指标
主要结局
Monocular Visual Acuity Assessment
时间窗: Post lens insertion (baseline)
Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Binocular Visual Acuity
时间窗: Post lens insertion (baseline)
Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value \<0 implies clinically positive results, a value \>0 implies clinically negative results
次要结局
- Bulbar Redness of Grade 3 or Above(After 6-8 days of lens wear)
- Limbal Redness of Grade 3 or Above(After 6-8 days of lens wear)