Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 473
- 试验地点
- 26
- 主要终点
- Lens Comfort
研究概览
简要总结
The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years old.
- •Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- •Require a visual correction in both eyes (monovision allowed but not monofit).
- •Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
- •Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
- •Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
- •Have normal eyes with no evidence of abnormality or 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 corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Worn lenses on an extended wear basis in the last 3 months.
- •Diabetic.
- •Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
- •Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- •Abnormal lacrimal secretions.
研究组 & 干预措施
02Optix CL and ReNu MPS with SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: O2Optix contact lens (Device)
02Optix CL and ReNu MPS with SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: ReNu MultiPlus Multi-Purpose Solution (Device)
Proclear CL and ReNu MPS with SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: Proclear contact lens (Device)
Proclear CL and ReNu MPS with SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: ReNu MultiPlus Multi-Purpose Solution (Device)
02Optix CL and Clear Care LCS with SICS
O2Optix contact lens and Clear Care lens care solution subject
干预措施: O2Optix contact lens (Device)
02Optix CL and Clear Care LCS with SICS
O2Optix contact lens and Clear Care lens care solution subject
干预措施: Clear Care Cleaning and Disinfecting Solution (Device)
Proclear CL and Clear Care LCS with SICS
Proclear contact lens and Clear Care lens care solution
干预措施: Proclear contact lens (Device)
Proclear CL and Clear Care LCS with SICS
Proclear contact lens and Clear Care lens care solution
干预措施: Clear Care Cleaning and Disinfecting Solution (Device)
02Optix CL and ReNu MPS without SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: O2Optix contact lens (Device)
02Optix CL and ReNu MPS without SICS
O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: ReNu MultiPlus Multi-Purpose Solution (Device)
Proclear CL and ReNu MPS without SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: Proclear contact lens (Device)
Proclear CL and ReNu MPS without SICS
Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
干预措施: ReNu MultiPlus Multi-Purpose Solution (Device)
02Optix CL and Clear Care LCS without SICS
O2Optix contact lens and Clear Care lens care solution
干预措施: O2Optix contact lens (Device)
02Optix CL and Clear Care LCS without SICS
O2Optix contact lens and Clear Care lens care solution
干预措施: Clear Care Cleaning and Disinfecting Solution (Device)
Proclear CL and Clear Care LCS without SICS
Proclear contact lens and Clear Care lens care solution
干预措施: Proclear contact lens (Device)
Proclear CL and Clear Care LCS without SICS
Proclear contact lens and Clear Care lens care solution
干预措施: Clear Care Cleaning and Disinfecting Solution (Device)
结局指标
主要结局
Lens Comfort
时间窗: 24 weeks
Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.
Average Daily Comfortable Wear Time
时间窗: 24 weeks
Average hours per day that contact lens were worn comfortably.
Frequency of Eye Discomfort
时间窗: 24 weeks
Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Limbal Redness
时间窗: 24 weeks
Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Frequency of Daily Lens Dryness
时间窗: 24 weeks
Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Frequency of Itching
时间窗: 24 weeks
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Frequency of Tearing
时间窗: 24 weeks
Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Average Corneal Fluorescein Staining Area
时间窗: 24 weeks
corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.
Average Daily Wear Time
时间窗: 24 weeks
Average hours per day that contact lens were worn.
Frequency of Eye Burning/Stinging
时间窗: 24 weeks
Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.
Tarsal Roughness
时间窗: 24 weeks
The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency \& superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae
Average Corneal Fluorescein Type Staining
时间窗: 24 weeks
staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.
Bulbar Redness
时间窗: 24 weeks
Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Upper Tarsal Redness
时间窗: 24 weeks
Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Lower Tarsal Redness
时间窗: 24 weeks
Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
次要结局
- Intensity of Physiological Outcomes(24 weeks)
- Wearing Time and Comfortable Wearing Time(24 weeks)
- Physiological Responses(24 weeks)