A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Lens Surface - Wettability - Hema-copolymer and Etafilcon A
研究概览
简要总结
This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.
详细描述
This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.
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
- •Subjects will only be eligible for the study if:
- •They are 18 years of age and above.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They agree not to participate in other clinical research for the duration of this study.
- •They can attain at least 6/9 in each eye with the study lenses within the available power range.
- •They can be fitted with study lenses within the available power range.
- •The currently use soft contact lenses, or have done so within the last six months.
排除标准
- •Subjects will not be able to take part in the study if:
- •They have an ocular disorder which would normally contraindicate contact lens wear.
- •They have a systemic disorder which would normally contraindicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They have had cataract surgery.
- •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 any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Biomicroscopy - Hema-copolymer and Etafilcon A
时间窗: 1 week
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Visual Acuity - Hema-copolymer and Etafilcon A
时间窗: 1 week
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Lens Surface - Debris - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
时间窗: 1 week
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
时间窗: 1 week
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
次要结局
未报告次要终点