Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 38
- 主要终点
- Lens Orientation
研究概览
简要总结
Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
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
- 是
入选标准
- •Be between 18 and 45 years of age.
- •Sign Written Informed Consent (See separate document).
- •Be an existing successful daily wear toric soft contact lens.
- •Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
- •Does not require presbyopic correction (can read J1 @ normal reading distance).
- •Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
- •Have refractive astigmatism between 0.75D and 2.50D in both eyes.
- •Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
- •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. stromal edema, vascularisation, infiltrates or abnormal opacities).
- •No other active ocular disease.
排除标准
- •Requires concurrent ocular medication.
- •Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Corneal staining Grade 3 in more than one region.
- •Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- •Abnormal lacrimal secretions.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Keratoconus or other corneal irregularity.
- •Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
- •Extended lens wear in last 3 months.
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Diabetic.
- •Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial or in last 60 days.
研究组 & 干预措施
senofilcon A toric
senofilcon A, daily wear, toric contact lens worn for two weeks
干预措施: senofilcon A toric (Device)
balafilcon A toric
balafilcon A, daily wear, toric contact lens worn for two weeks
干预措施: balafilcon A toric (Device)
结局指标
主要结局
Lens Orientation
时间窗: 1 minute after insertion
Proportion of eyes with lens orientation within 5 degrees of optimal
Lens Stability
时间窗: 10-15 minutes after insertion
Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Subjective Comfort
时间窗: 2 weeks of lens wear
Subjective comfort was derived from 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. \>0 = comfortable, \< 0 = uncomfortable. Combined measures from Week 1 and Week 5.
次要结局
- Time to Fit Lens(after lens insertion)
- Subjective Lens Vision(measured at 1 and 2 weeks)
- Overall Corneal Staining(After 2 weeks use)