Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations.
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. The other lens (control) is a commercially available contact lens.
The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested.
Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 20 years or more.
- •Sign written informed consent.
- •Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment).
- •Contact lens sphere requirement between -1.00 to -6.00 D (inclusive).
- •Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes.
- •Be correctable by sphero-cylindrical refraction to 6/7.5 (+0.10 logMAR 0.8 decimal) or better in each eye.
- •Require visual correction in both eyes (monovision allowed, no monofit.
排除标准
- •Require toric or multifocal contact lenses.
- •Concurrent ocular medication.
- •Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- •Any systemic illness affecting contact lens wear or the medical treatment of which would affect vision or successful lens wear (including diabetes).
- •Clinically significant (≥Grade 2) corneal staining, corneal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •History of herpetic keratitis.
- •Pathological dry eye.
- •Aphakia or amblyopia.
- •History of refractive surgery, keratoconus or other corneal irregularity.
- •Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial or within the last 30 days.
研究组 & 干预措施
Silicone hydrogel soft contact lens CE-marked for daily use
干预措施: CE-marked Silicone hydrogel soft contact lens (Device)
DSiHy (test lens)
干预措施: DSiHy Silicone hydrogel soft contact lens (Device)
结局指标
主要结局
Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations.
时间窗: 13 week visit
Proportion of eyes with visual acuity corrected to 6/6 or better (1.0 decimal) at each visit.
时间窗: 13 week visit
Proportion of eyes with best sphere-corrected visual acuity of 6/6 or better (1.0 decimal) at each visit.
时间窗: 13 week visit
次要结局
- The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4)(13 week visit)
- The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4)(13 week visit)
- The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4).(13 week visit)
- The following variables will be compared between lens types: Comfort (0-10)(13 week visit)
- The following variables will be compared between lens types: Visual acuity (logMAR VA)(13 week visit)
- The following variables will be compared between lens types: Wettability (0-4).(13 week visit)