NCT01552876已完成不适用
Comparative Clinical Evaluation of Soft Toric Lens Designs
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Phase I: Absolute Lens Rotation
研究概览
简要总结
This study is evaluating the initial fit of toric 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be greater than or equal to 18 years old.
- •Read, understand, and sign written Statement of Informed Consent.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be existing 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 spherical contact lens requirement in the range -0.50D to -6.00D.
- •Have astigmatism of between -0.50 and -2.00DC in both eyes.
- •Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
- •Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery
排除标准
- •Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
- •Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Extended lens wear in last 3 months.
- •Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- •Any systemic disease affecting ocular health.
- •Abnormal lacrimal secretions.
- •Keratoconus or other corneal irregularity.
- •Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial.
- •Any previous anterior ocular surgery.
- •Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
- •Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
- •Subjects who are known to have diabetes.
- •Employees or family members of the Research site, Principal Investigator or study team.
研究组 & 干预措施
etafilcon A / nelfilcon A / Filcon II 3
Other
etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.
干预措施: Filcon II 3 (Device)
etafilcon A / nelfilcon A / Filcon II 3
Other
etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.
干预措施: etafilcon A (Device)
etafilcon A / nelfilcon A / Filcon II 3
Other
etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.
干预措施: nelfilcon A (Device)
nelfilcon A / etafilcon A / Filcon II 3
Other
nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.
干预措施: etafilcon A (Device)
nelfilcon A / etafilcon A / Filcon II 3
Other
nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.
干预措施: nelfilcon A (Device)
nelfilcon A / etafilcon A / Filcon II 3
Other
nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.
干预措施: Filcon II 3 (Device)
结局指标
主要结局
Phase I: Absolute Lens Rotation
时间窗: 3 min after lens insertion during Phase I
Lens orientation position as assessed on a scale of 0-180 on both eyes.
次要结局
- Phase I: Time to Lens Settling(5 minutes after lens insertion during Phase I)
- Phase I: Number of Blinks Until Settled(Baseline to 5 minutes during Phase I)
研究者
研究点 (1)
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