Evaluation of Tangible Boost Replenishing System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Non-invasive Tear Film Break-up Time
研究概览
简要总结
This study will evaluate Tangible Boost, a new contact lens care product which is designed to replenish the hydrogel layer on fluorosilicone acrylate lenses with Hydra-PEG. The Hydra-PEG coating is a poly(ethylene glycol)-based hydrogel that is covalently bound to the lens surface. This coating improves lens wettability, a common cause of patient discomfort. Tangible Boost is designed to maintain the wettability of Hydra-PEG lenses throughout the lens lifetime. Patients can use the Tangible Boost kit to reapply the Hydra-PEG coating each month at home.
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, Care Provider)
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
- •Habitual contact lens wear with a group 3 FDA approved rigid lens material, with 20-50% of subjects wearing corneal lenses
- •Willing and able to sign the informed consent form
- •18 years or older
排除标准
- •Eye injury or surgery within the 3 months immediately prior to enrollment for this trial
- •Pre-existing ocular irritation that would preclude contact lens fitting
- •Current enrollment in an ophthalmic clinical trial
- •Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
- •Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator
- •Pregnant women and nursing mothers
- •Visual acuity less than 20/20 when best corrected with contact lenses
结局指标
主要结局
Non-invasive Tear Film Break-up Time
时间窗: 1 day after treatment (day 31), final assessment (day 90)
Tear break-up time was measured with the OCULUS Keratograph.
Number of Participants With Acceptable Lens Fit
时间窗: final assessment (day 90)
Count of participants with acceptable lens fit (movement, centration, apical clearance, limbal clearance, and landing zone).
Number of Patients With Adverse Event Reports or Discontinuations
时间窗: Duration of study, 90 +/- 7 days after lens dispense visit.
A report of any adverse events or discontinuations that may have occurred. This measure includes adverse events unrelated to the treatment. See adverse events section for additional details.
Corneal Staining
时间窗: 1 day after treatment (day 31), final assessment (day 90)
Corneal staining with lissamine green was used to identify damage to the corneal cells, which may have been caused by the contact lenses or treatments in the study. 5 regions in each eye were scored on a scale of 0-4, resulting in a total possible range of 0-20. Left and right eye scores were averaged for each subject. A lower score indicates less corneal damage.
Visual Acuity
时间窗: 1 day after treatment (day 31), final assessment (day 90)
Visual acuity was calculated on a logMAR scale using high luminance, high contrast acuity charts. On the logMAR scale, a score of 0 indicates no vision loss, with higher scores indicating more vision loss.
次要结局
- CLDEQ Score(1 day after treatment (day 31), final assessment (day 90))
- Visual Analog Scale (VAS)(1 day after treatment (day 31), final assessment (day 90))