Clinical Biocompatibility Evaluation of Contact Lens Coatings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Average Percent Area of Solution-related Corneal Staining
研究概览
简要总结
The primary objective is to evaluate corneal staining observed after 2 hours of wear with contact lenses with investigational coating against PureVision™ lenses, all pre-cycled with OPTI-FREE® RepleniSH® multi-purpose disinfection solution.
详细描述
In this contralateral crossover study, qualifying subjects will wear a total of 2 pairs of study contact lenses. Lenses will be worn according to a randomized lens sequence assignment. Each pair will consist of a test lens (Test 1 or Test 2) and a control lens.
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)
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
- •Able to understand and must sign an Informed Consent;
- •Successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Manifest cylinder less than or equal to 1.50 diopter (D) in each eye;
- •Best Corrected Visual Acuity (BCVA) 20/25 or better in each eye;
- •VA with habitual spectacles 20/40 in both eyes (OU) or better and willing to wear spectacles as needed during the washout period and during study lens exposure;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- •History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye;
- •Ocular or intra-ocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
- •Current or history of pathologically dry eye in either eye that would preclude contact lens wear;
- •Current or history of herpetic keratitis in either eye;
- •Eye injury in either eye within 12 weeks immediately prior to enrollment;
- •History of intolerance or hypersensitivity to any component of the study lenses or solutions;
- •Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- •Use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Test 1/Control 1, then Control 2/Test 2
Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 1 (Device)
Test 1/Control 1, then Control 2/Test 2
Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Balafilcon A contact lens (Device)
Test 1/Control 1, then Control 2/Test 2
Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: OPTI-FREE® RepleniSH® MPDS (Device)
Test 1/Control 1, then Control 2/Test 2
Contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 2 (Device)
Test 2/Control 2, then Control 1/Test 1
Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 1 (Device)
Test 2/Control 2, then Control 1/Test 1
Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Balafilcon A contact lens (Device)
Test 2/Control 2, then Control 1/Test 1
Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: OPTI-FREE® RepleniSH® MPDS (Device)
Test 2/Control 2, then Control 1/Test 1
Contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 1, followed by balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 2 (Device)
Control 1/Test 1, then Test 2/Control 2
Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 1 (Device)
Control 1/Test 1, then Test 2/Control 2
Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Balafilcon A contact lens (Device)
Control 1/Test 1, then Test 2/Control 2
Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: OPTI-FREE® RepleniSH® MPDS (Device)
Control 1/Test 1, then Test 2/Control 2
Balafilcon A contact lens in right eye, with contact lens with investigational coating 1 in left eye during Period 1, followed by contact lens with investigational coating 2 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 2 (Device)
Control 2/Test 2, then Test 1/Control 1
Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 1 (Device)
Control 2/Test 2, then Test 1/Control 1
Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Balafilcon A contact lens (Device)
Control 2/Test 2, then Test 1/Control 1
Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: OPTI-FREE® RepleniSH® MPDS (Device)
Control 2/Test 2, then Test 1/Control 1
Balafilcon A contact lens in right eye, with contact lens with investigational coating 2 in left eye during Period 1, followed by contact lens with investigational coating 1 in right eye, with balafilcon A contact lens in left eye during Period 2. Each lens pair worn contralaterally for approximately 2 hours, with 2 to 8 days between pairs.
干预措施: Contact lens with investigational coating 2 (Device)
结局指标
主要结局
Average Percent Area of Solution-related Corneal Staining
时间窗: Day 1 after 2 hours of wear, each product
Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.
次要结局
未报告次要终点