NCT04613882已完成不适用
Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.
详细描述
This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will only be eligible for the study if:
- •They are of legal age between 18 and 40 years.
- •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 are current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
- •They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
- •They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
- •They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
- •They can be fitted satisfactorily with both lens types.
- •They own an acceptable pair of spectacles.
- •They agree not to participate in other clinical research for the duration of this study.
排除标准
- •Subjects will not be eligible to take part in the study if:
- •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 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 breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
- •They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
- •They have a history of severe allergic reaction or anaphylaxis.
- •They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Visual Acuity
时间窗: After 30 minutes of dispense (High Contrast VA)
Visual acuity was assessed using logMAR for each intervention.
次要结局
- Slit Lamp Biomicroscopy Findings - Corneal Staining(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Corneal Oedema(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Staining(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Conjunctival Redness(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Limbal Redness(At Exit (After 30 minutes in each of three interventions))
- Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis(At Exit (After 30 minutes in each of three interventions))
研究者
研究点 (2)
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