Corneal Staining Evaluation of SiH MPDS FID 114675A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- Solution-Related Corneal Staining
研究概览
简要总结
The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years of age or older.
- •Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
- •Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit
- •Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
- •Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
- •Monocular vision (only one eye with functional vision) or fit with only one contact lens.
- •Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
- •Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
- •Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
- •Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
- •Corneal staining area assessment ≥ 20% in any corneal region in either eye at baseline visit.
- •Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
- •Participation in any investigational clinical study within 30 days of baseline visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FID 114675A
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
干预措施: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) (Device)
FID 114675A
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
干预措施: Etafilcon A contact lens (ACUVUE® 2™) (Device)
FID 114675A
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
干预措施: Senofilcon A contact lens (ACUVUE® OASYS™) (Device)
FID 114675A
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
干预措施: Lotrafilcon B contact lens (O2 OPTIX®) (Device)
FID 114675A
FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only.
干预措施: Balafilcon A contact lens (PureVision®) (Device)
结局指标
主要结局
Solution-Related Corneal Staining
时间窗: Day 7
Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes.
次要结局
- Mean Lens Comfort(Day 7)