NCT06251154已完成不适用
A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Subjective Overall Score
研究概览
简要总结
This study was designed to gather short-term clinical performance data for 2 soft contact lenses.
详细描述
The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 were of legal age (18) and capacity to volunteer.
- •They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
- •They were willing and able to follow the protocol.
- •They were wearing soft contact lenses, or had done so within the past two years.
- •They were able to be fitted with the study lenses within the power range available.
排除标准
- •Subjects will not be eligible if:
- •They had an ocular disorder which would normally contra-indicate contact lens wear.
- •They had a systemic disorder which would normally contra-indicate contact lens wear.
- •They were using any topical medication such as eye drops or ointment.
- •They were aphakic.
- •They had had corneal refractive surgery.
- •They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
- •They were pregnant or lactating.
- •They had an eye or health condition including an immunosuppressive or infectious disease which could, 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 had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
结局指标
主要结局
Subjective Overall Score
时间窗: 15 minutes
Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall
次要结局
- Subjective Vision(15 minutes)
- Subjective Comfort(15 minutes)
研究者
研究点 (2)
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