BIOCLEAN FIRST CARE EX in Combination With Biofinity Lens: A Two Week Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Ocular Health - Limbal Redness
研究概览
简要总结
To determine if patients are unreactive to the lens care solution / Biofinity combination.
详细描述
To determine if patients are unreactive to the lens care solution / Biofinity combination in this cross-over study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Is over 18 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Is currently an adapted spherical soft CL wearer
- •Has a CL spherical prescription between - 0.25 and - 12.00 (inclusive)
- •Has less than 1.00D spectacle cylinder in each eye.
- •Is correctable to a visual acuity of 20/20 or better in both eyes
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the information consent letter.
- •Is willing to comply with the wear schedule (at least 40 hrs per week)
- •Is willing to comply with the visit schedule
排除标准
- •Has never worn contact lenses before.
- •Currently wears rigid gas permeable contact lenses.
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has a CL prescription outside the range of - 0.25 to -12.00D
- •Has a spectacle cylinder greater than -0.75D of cylinder in either eye.
- •Has best corrected spectacle distance vision worse than 20/20 in either eye.
- •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
- •Has persistent, clinically significant corneal or conjunctival staining
- •Has active neovascularization or any central corneal scars.
- •Is aphakic.
- •Is pregnant or lactating.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
结局指标
主要结局
Ocular Health - Limbal Redness
时间窗: 1 week
Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Corneal Staining
时间窗: 1 week
Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Papillary Conjunctivitis
时间窗: 1 week
Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
Ocular Health - Conjunctival Redness
时间窗: 1 week
Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).
次要结局
- Stinging Sensation Right After Insertion (Subjective Rating)(Baseline)
- Burning Sensation Right After Insertion (Subjective Rating)(Baseline)