NCT00349843已完成4 期
Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The primary objective of this study is to compare corneal staining over time in
研究概览
简要总结
The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.
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
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
- •Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
- •Is correctable to a visual acuity of 6/6 or better with their habitual correction.
- •Is willing and able to follow product usage instructions and maintain the visit schedule.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Can be successfully fitted with study lens type.
- •Has read, understood and signed an Information Consent Letter.
- •Has a distance contact lens prescription is between -0.50 D and -9.00 D
- •Has astigmatism of ≤ 1.00 D Cyl
- •Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of ≤ 1.00D
- •Has no systemic disease affecting ocular health.
- •Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
- •Has clear corneas and no active ocular disease.
- •Has no known ocular or systemic allergies, which could interfere with contact lens wear.
- •Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.
- •Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
- •Has not worn extended wear contact lenses in the last 30 days.
- •Has had an oculo-visual examination in the last two years
排除标准
- •Has any active ocular disease.
- •Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
- •Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
- •Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
- •Is using topical ocular prescription or any topical over-the-counter medication.
- •Is actively involved in any other research/clinical study.
- •Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
- •Has had corneal refractive surgery.
- •Has known sensitivity to any of the study solutions.
结局指标
主要结局
The primary objective of this study is to compare corneal staining over time in
a group of individuals who wear soft contact lenses on a daily wear basis,
whilst they sequentially use two different contact lens care regimens.
次要结局
- The secondary objective of this study is to compare subjective ocular symptoms
- over time in a group of individuals who wear soft contact lenses on a daily wear
- basis, whilst they sequentially use two different contact lens care regimens.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Corneal and Conjunctival Sensitivity and Staining StudyMyopiaHyperopiaNCT00455455University of Waterloo50
已完成
4 期
Pilot Evaluation of Two Multipurpose Solutions in Regards to Corneal StainingCorneal StainingNCT00483795Innovative Medical
已完成
不适用
Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose SolutionsCorneal StainingNCT01240122Abbott Medical Optics30
已完成
不适用
Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens WearContact Lens-induced Corneal Fluorescein StainingNCT01015768Southern California College of Optometry at Marshall B. Ketchum University30
已完成
不适用
7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens WearersContact Lens CareNCT00884806Alcon Research110