Vistakon Investigational Contact Lenses Worn for Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 40
- 主要终点
- Subject Reported Symptoms
研究概览
简要总结
This study compares the performance of an investigational contact lens to a currently marketed lens.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •The subject must be at least 18 years of age.
- •Both males and females may be enrolled.
- •The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.
- •The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.
排除标准
- •The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.
- •Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
- •Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
- •The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.
- •Moderate or above corneal distortion by keratometry.
- •Known allergy to silver, silver ions, or silver containing compounds.
- •Abnormal discoloration of the cornea and/or conjunctiva.
- •Routine exposure to silver, silver ions, or silver containing compounds.
- •The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS)
- •Free of systemic and infectious diseases: hepatitis and tuberculosis.
- •Subjects must be HIV negative.
- •The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).
- •The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.
- •The subject must not have more than 1.00D of refractive astigmatism in either eye.
- •The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.
- •The subject must not be monovision corrected.
- •The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.
- •The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars)
- •The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.
- •The subject must not have had an eye injury within 8 weeks prior to study enrollment.
- •The subject must not have had previous eye surgery.
- •The subject must be successfully trial fitted with the study contact lenses.
结局指标
主要结局
Subject Reported Symptoms
时间窗: 6 months
Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.
Average Contact Lens Wear Time
时间窗: 6 Months
The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.
Slit Lamp Findings
时间窗: 6 months
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Visual Acuity
时间窗: 6 months
Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.
次要结局
未报告次要终点