The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 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.
研究组 & 干预措施
Lens A, then Lens B
Participants wore Lens A for one week, then crossed over to wear Lens B for one week.
干预措施: Lens A (delefilcon A) (Device)
Lens A, then Lens B
Participants wore Lens A for one week, then crossed over to wear Lens B for one week.
干预措施: Lens B (stenfilcon A) (Device)
Lens B, then Lens A
Participants wore Lens B for one week, then crossed over to wear Lens A for one week.
干预措施: Lens A (delefilcon A) (Device)
Lens B, then Lens A
Participants wore Lens B for one week, then crossed over to wear Lens A for one week.
干预措施: Lens B (stenfilcon A) (Device)
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)