Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Acuity After Infero-nasal Version Movement.
研究概览
简要总结
The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).
详细描述
Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are aged between 18-39 years.
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They can attain at least 6/9 in each eye with their spectacle refraction.
- •They have successfully worn contact lenses within six months of starting the study.
- •They can be fitted with toric soft contact lenses to match the available power range.
排除标准
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or lactating.
- •They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
研究组 & 干预措施
Group 2 LSBO
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
干预措施: senofilcon A (Device)
Group 2 LSBO
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
干预措施: balafilcon A (Device)
Group 2 LSBO
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
干预措施: omafilcon A (Device)
Group 2 LSBO
contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
干预措施: lotrafilcon B (Device)
Group 3 LOSB
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
干预措施: senofilcon A (Device)
Group 3 LOSB
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
干预措施: balafilcon A (Device)
Group 3 LOSB
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
干预措施: omafilcon A (Device)
Group 3 LOSB
contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
干预措施: lotrafilcon B (Device)
Group 5 LBOS
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
干预措施: senofilcon A (Device)
Group 5 LBOS
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
干预措施: balafilcon A (Device)
Group 5 LBOS
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
干预措施: omafilcon A (Device)
Group 5 LBOS
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
干预措施: lotrafilcon B (Device)
Group 4 LBSO
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
干预措施: senofilcon A (Device)
Group 4 LBSO
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
干预措施: balafilcon A (Device)
Group 4 LBSO
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
干预措施: omafilcon A (Device)
Group 4 LBSO
contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
干预措施: lotrafilcon B (Device)
Group 6 SLOB
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
干预措施: senofilcon A (Device)
Group 6 SLOB
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
干预措施: balafilcon A (Device)
Group 6 SLOB
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
干预措施: omafilcon A (Device)
Group 6 SLOB
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric
干预措施: lotrafilcon B (Device)
Group 7 SLBO
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
干预措施: senofilcon A (Device)
Group 7 SLBO
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
干预措施: balafilcon A (Device)
Group 7 SLBO
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
干预措施: omafilcon A (Device)
Group 7 SLBO
contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
干预措施: lotrafilcon B (Device)
Group 8 SOLB
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: senofilcon A (Device)
Group 8 SOLB
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: balafilcon A (Device)
Group 8 SOLB
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: omafilcon A (Device)
Group 8 SOLB
contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: lotrafilcon B (Device)
Group 9 SBLO
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
干预措施: senofilcon A (Device)
Group 9 SBLO
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
干预措施: balafilcon A (Device)
Group 9 SBLO
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
干预措施: omafilcon A (Device)
Group 9 SBLO
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
干预措施: lotrafilcon B (Device)
Group 10 SBOL
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: senofilcon A (Device)
Group 10 SBOL
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: balafilcon A (Device)
Group 10 SBOL
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: omafilcon A (Device)
Group 10 SBOL
contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: lotrafilcon B (Device)
Group 11 OSLB
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: senofilcon A (Device)
Group 11 OSLB
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: balafilcon A (Device)
Group 11 OSLB
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: omafilcon A (Device)
Group 11 OSLB
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
干预措施: lotrafilcon B (Device)
Group 12 OSBL
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
干预措施: senofilcon A (Device)
Group 12 OSBL
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
干预措施: balafilcon A (Device)
Group 12 OSBL
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
干预措施: omafilcon A (Device)
Group 12 OSBL
contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
干预措施: lotrafilcon B (Device)
Group 13 OBLS
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: senofilcon A (Device)
Group 13 OBLS
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: balafilcon A (Device)
Group 13 OBLS
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: omafilcon A (Device)
Group 13 OBLS
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: lotrafilcon B (Device)
Group 14 OBSL
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: senofilcon A (Device)
Group 14 OBSL
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: balafilcon A (Device)
Group 14 OBSL
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: omafilcon A (Device)
Group 14 OBSL
contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: lotrafilcon B (Device)
Group 15 BLSO
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
干预措施: senofilcon A (Device)
Group 15 BLSO
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
干预措施: balafilcon A (Device)
Group 15 BLSO
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
干预措施: omafilcon A (Device)
Group 15 BLSO
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
干预措施: lotrafilcon B (Device)
Group 16 BLOS
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
干预措施: senofilcon A (Device)
Group 16 BLOS
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
干预措施: balafilcon A (Device)
Group 16 BLOS
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
干预措施: omafilcon A (Device)
Group 16 BLOS
contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
干预措施: lotrafilcon B (Device)
Group 17 BSOL
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: senofilcon A (Device)
Group 17 BSOL
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: balafilcon A (Device)
Group 17 BSOL
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: omafilcon A (Device)
Group 17 BSOL
contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric
干预措施: lotrafilcon B (Device)
Group 18 BOLS
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: senofilcon A (Device)
Group 18 BOLS
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: balafilcon A (Device)
Group 18 BOLS
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: omafilcon A (Device)
Group 18 BOLS
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
干预措施: lotrafilcon B (Device)
Group 19 BOSL
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: senofilcon A (Device)
Group 19 BOSL
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: balafilcon A (Device)
Group 19 BOSL
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: omafilcon A (Device)
Group 19 BOSL
contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
干预措施: lotrafilcon B (Device)
Group 1 LSOB
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
干预措施: senofilcon A (Device)
Group 1 LSOB
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
干预措施: balafilcon A (Device)
Group 1 LSOB
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
干预措施: omafilcon A (Device)
Group 1 LSOB
contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric
干预措施: lotrafilcon B (Device)
结局指标
主要结局
Visual Acuity After Infero-nasal Version Movement.
时间窗: 10 minutes after lens insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity After Superior-temporal Version Movement
时间窗: 10 minutes after lens insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity After Superior-nasal Version Movement.
时间窗: 10 minutes after lens insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Visual Acuity After Infero-temporal Version Movement.
时间窗: 10 minutes after insertion
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
次要结局
未报告次要终点