Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 25
- 主要终点
- Average Corneal Staining
研究概览
简要总结
The purpose of this study is to compare the clinical performance of two contact lenses.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing daily soft lens wearer.
- •Require a distance visual correction in both eyes.
- •Have a contact lens spherical distance refraction between -1.00D and -6.00D.
- •Have refractive astigmatism less than or equal to 1.00D in both eyes.
- •Achieve 20/30 or better corrected distance acuity.
- •Have normal eyes with no evidence of abnormality or disease.
排除标准
- •Requires presbyopic correction.
- •Requires ocular medications.
- •Grade 3 or 4 ocular abnormalities.
- •Grade 3 corneal staining in more than one region.
- •Has had refractive surgery.
- •Any other injury or ocular surgery within 8 weeks prior to study enrollment.
- •Has abnormal lacrimal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Has keratoconus or other corneal irregularity.
- •Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
- •Wears habitual contact lenses that are toric, multifocal or worn extended wear.
- •Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
- •Diabetic.
- •Infectious or immunosuppressive disease.
- •History of chronic eye disease (e.g glaucoma or age related macular degeneration).
- •Pregnancy, lactation or planning pregnancy at time of enrollment.
- •Participation in any concurrent clinical trial or in another trial in the last 30 days.
研究组 & 干预措施
senofilcon A both eyes
soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
干预措施: senofilcon A (Device)
lotrafilcon B both eyes
soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen
干预措施: lotrafilcon B (Device)
结局指标
主要结局
Average Corneal Staining
时间窗: 2 weeks
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Visual Acuity
时间窗: 2 weeks
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Overall Comfort
时间窗: 2 weeks and 4 weeks
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
次要结局
- Limbal Redness(2 weeks)
- Bulbar Redness(2 weeks)
- Symptoms of Dryness(2 weeks)