Clinical Evaluation of Two Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lens Comfort
研究概览
简要总结
This study seeks to evaluate the clinical performance of two daily disposable contact lenses.
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
- 21 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 21 and 39 years of age.
- •Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- •Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- •Require a visual correction in both eyes (monovision allowed but no monofit).
- •Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
- •Astigmatism of 1.00D or less in both eyes.
- •Be able to wear the lens powers available for this study.
- •Be correctable to a visual acuity of 20/30 or better in each eye.
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection.
- •No conjunctival abnormality or infection.
- •No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
- •No other active ocular disease.
排除标准
- •Requires concurrent ocular medication.
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Diabetic.
- •Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •Extended lens wear in last 3 months.
- •PMMA or RGP lens wear in the previous 8 weeks.
- •Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- •Abnormal lacrimal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- •Participation in any concurrent clinical trial or in last 60 days."
研究组 & 干预措施
etafilcon A / ocufilcon D
etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
干预措施: etafilcon A (Device)
etafilcon A / ocufilcon D
etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable
干预措施: ocufilcon D (Device)
oculfilcon D / etafilcon A
ocufilcon D contact lens worn first, etafilcon A contact lens worn second
干预措施: etafilcon A (Device)
oculfilcon D / etafilcon A
ocufilcon D contact lens worn first, etafilcon A contact lens worn second
干预措施: ocufilcon D (Device)
ocufilcon D / ocufilcon D
ocufilcon D contact lens worn first and second
干预措施: ocufilcon D (Device)
etafilcon A / etafilcon A
etafilcon A contact lens worn first and second
干预措施: etafilcon A (Device)
结局指标
主要结局
Lens Comfort
时间窗: 1-week follow-up
Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)
次要结局
- Comfort Throughout the Whole Day(1-week follow-up)