Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Lens Deposits
研究概览
简要总结
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.
详细描述
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer.
- •Has read, understood and signed an information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
- •Has clear corneas and no active ocular disease.
- •Has had an ocular examination in the last two years.
- •Is a current soft lens wearer, replacing their lenses every two weeks to one month.
- •Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
- •Has astigmatism less than or equal to -1.00 DC.
排除标准
- •Has any signs or symptoms of dry eye.
- •Has any clinically significant blepharitis.
- •Has undergone corneal refractive surgery.
- •Is aphakic.
- •Has any active ocular disease.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that may affect ocular health.
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- •Is pregnant or lactating.
- •Is participating in any other type of clinical or research study.
- •Currently wears daily disposable lenses.
- •Currently wears lenses on an extended wear basis.
研究组 & 干预措施
Phase1 - Arm 1
干预措施: Alcon Opti-Free® RepleniSH® with Supraclens® (Drug)
Phase1 - Arm 1
干预措施: Alcon Opti-Free® RepleniSH® (Drug)
Phase1 - Arm 2
干预措施: Alcon Opti-Free® RepleniSH® with Supraclens® (Drug)
Phase1 - Arm 2
干预措施: Alcon Opti-Free® RepleniSH® (Drug)
Phase 2 - Arm 1
干预措施: Alcon Opti-Free® RepleniSH® with Supraclens® (Drug)
Phase 2 - Arm 1
干预措施: B&L ReNu MultiPlus™ (Drug)
Phase 2 - Arm 2
干预措施: Alcon Opti-Free® RepleniSH® with Supraclens® (Drug)
Phase 2 - Arm 2
干预措施: B&L ReNu MultiPlus™ (Drug)
结局指标
主要结局
Lens Deposits
时间窗: 4 weeks
Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
Comfort
时间窗: 4 weeks
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Lens Wettability
时间窗: 4 weeks
Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
次要结局
- Subjective Vision(4 weeks)
- Dryness(4 weeks)
- Corneal Staining(4 weeks)