A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Corneal Staining Severity
研究概览
简要总结
This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.
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
- 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
- 是
入选标准
- •Informed Consent and HIPAA document read, signed, and dated.
- •Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
- •Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.
排除标准
- •History of hypersensitivity
- •Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
- •One functional eye or a monofit eye
- •Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
- •Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
- •Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
- •Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
- •Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
- •Abnormal lenticular opacity in the visual axis of the lens in either eye
- •Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
- •History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
- •Pregnant or lactating females
结局指标
主要结局
Corneal Staining Severity
时间窗: Baseline, 2 Hour Period, 4 Hour Period
Severity of staining was recorded for each region using a scale of 0-none to 4-patch \>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Corneal Staining Area
时间窗: Baseline, 2 Hour Period, 4 Hour Period
Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.
次要结局
- Subjective Comfort(Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours)
- Subjective Dryness(Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours)