NCT05794126已完成不适用
A Clinical Comparison of Two Soft Multifocal Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Subjective Overall Score
研究概览
简要总结
The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.
详细描述
The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.
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
- 42 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They were at least 42 years of age and had capacity to volunteer.
- •They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
- •They had had a full eye examination within the past two years (by self-report).
- •They were willing and able to follow the protocol.
- •They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
- •They had refractive astigmatism of no greater than -0.75DC.
- •They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.
排除标准
- •Subjects were not eligible to take part in the study 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.
结局指标
主要结局
Subjective Overall Score
时间窗: 15 Minutes
Subjective Overall Score was assessed using the 0-100 visual analogue scale where 0=Extremely poor, 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 (1)
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