A Dispensing Clinical Trial of Invigor I Lens Against Clariti Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- Overall Lens Fit Acceptance
研究概览
简要总结
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.
详细描述
Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed silicone- hydrogel contact lens (control), when worn on a daily basis for 1 month.
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
- Double (Participant, Investigator)
盲法说明
This will be a double-masked study in which both participant and investigator will be masked.
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
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and understood the information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- •Currently wears soft contact lenses.
- •Requires spectacle lens powers between -0.75 to -6.50 diopters sphere (0.25D steps).
- •Has no more than 0.75 diopters of refractive astigmatism.
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination.
- •Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
排除标准
- •Has never worn contact lenses before.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
- •Known allergy to a product used in this study (ex. Shellfish allergy)
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
结局指标
主要结局
Overall Lens Fit Acceptance
时间窗: 4-Weeks
Overall lens fit acceptance was measured on a scale of 0-4, 0.25 steps (0 Unacceptable-Can't be worn, 1 Acceptable -Poor/worn under supervision, 2 Acceptable -Fair, prefer refit, 3 Acceptable -Good, 4-Acceptable -Optimum)
Percentage of Participants With Optimum, Slightly Decentered, Extremely Decentered Lens Centration
时间窗: 4-weeks
Lens Centration was assessed in primary gaze, white light, diffuse, 8xmag, with graticule on a grade of Optimum, Slightly decentered (\<0.5mm), Extremely decentered (\>0.5mm)
Lens Surface Wettability
时间窗: 4-weeks
Lens surface wettability was measured on a scale of 0-4, 0.25 steps (0 Very Poor: Immediately displaying non-wetting areas on the lens surface, immediate drying time, 1 Poor: Irregular surface appearance, drying time \<\< blink time, 2 Acceptable: Smooth surface appearance immediately, after the blink becoming irregular after a while, drying time ≤ blink time, 3 Good: Typical soft lens appearance with long drying time 4 Excellent: Appearance of a healthy cornea with very long drying time)
Lens Surface Deposits
时间窗: 4-weeks
Lens surface deposits was measured on a Scale 0-4, 0.25 steps (0: Clean, no deposits,1: 5 or less small deposits (\<0.1mm), 2: \>5 deposits of \<0.1mm size or film covering 25-50% of surface, 3: Deposits of between 0.1 and 0.5mm or film covering 50-75% of surface, 4: Deposits of 0.5mm or larger or film covering more than 75% of surface)
次要结局
- Limbal Conjunctiva Hyperaemia(4-weeks)
- Bulbar Conjunctiva Hyperaemia(4-weeks)