NCT05020990已完成不适用
The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Subjective Handling Rating on Lens Removal
研究概览
简要总结
This study aimed to compare the clinical performance of two daily disposable toric contact lenses.
详细描述
This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.
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
- •They are at least 18 years old and have the capacity to volunteer.
- •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 currently wear soft contact lenses or have done so in the past two years.
- •They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
- •They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
- •They can be satisfactorily fitted with the study lens types.
- •At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- •They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- •They own a wearable pair of spectacles.
- •They agree not to participate in other clinical research while enrolled on this study.
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 breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
- •They are currently wearing one of the study contact lenses.
- •They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Subjective Handling Rating on Lens Removal
时间窗: One week
Subjective handling rating on lens removal was measured on a scale of 0-100 where 0=Unmanageable and 100=Excellent removal.
次要结局
- Overall Lens Fit at Follow-up(One Week)
- Biomicroscopy Score at Follow-up(One week)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Clinical Comparison of Two Daily Disposable Toric LensesMyopiaAstigmatismNCT01362894CIBA VISION240
已完成
不适用
Clinical Comparison of Two Daily Disposable Soft Contact LensesRefractive ErrorsMyopiaNCT03518008Alcon Research22
已完成
不适用
Clinical Evaluation of Two Toric Soft Contact LensesAstigmatismNCT06490302CooperVision, Inc.40
已完成
不适用
Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3AmetropiaMyopiaNCT04942925Alcon Research60
已完成
不适用
Clinical Evaluation of Two Daily Disposable Contact LensesRefractive ErrorNCT01163760Johnson & Johnson Vision Care, Inc.50