NCT00382681已完成不适用
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses
研究概览
简要总结
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
- •Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
- •Successful lens wear for at least 8 hours per day.
- •Vision correctable to 20/
- •Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
- •No corneal surgery within the past 12 months.
- •No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
- •No over-the-counter or prescription ocular medication.
- •No enrollment in another clinical study within 30 days prior to enrollment.
排除标准
- 未提供
结局指标
主要结局
Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses
时间窗: Day 90
次要结局
- Average Lens Wearing Time(Day 90)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic PatientsContact Lens CareNCT00382603Alcon Research362
已完成
不适用
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact LensesContact Lens CareNCT00382902Alcon Research233
已完成
3 期
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial FibrillationAtrial FibrillationNCT03683030Biosense Webster, Inc.397
已完成
不适用
Clinical Investigation on the Use of Ophthalmic Solution Based on Sodium Hyaluronate in Treatment of Eye DiscomfortOcular DrynessNCT05777798SIFI SpA28
已完成
不适用
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault ProlapseUrinary Incontinence, StressMixed IncontinenceVaginal Vault ProlapseNCT00223106Medtronic - MITG467