NCT02356692已完成不适用
Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Comfort at Insertion
研究概览
简要总结
The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.
详细描述
This was a non-dispensing, single-masked, randomized, contralateral study comparing Enfilcon A (test) against Senofilcon A (control). Each subject was randomized to wear the test lens in one eye and the control lens in the other eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Based on his/her knowledge, must be in good general health.
- •Be 18 to 38 years old.
- •Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
- •Read, indicate understanding of, and sign Written Informed Consent.
- •Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
- •Require a visual correction in both eyes.
- •Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
- •Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
- •lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- •No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
- •No aphakia.
排除标准
- •0.75D or greater of refractive astigmatism in either eye.
- •Presbyopic or current monovision contact lens wear.
- •Cannot be currently wearing either lenses (Avaira or Oasys).
- •Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
- •Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear such as:
- •Pathological dry eye or associated findings
- •Pterygium, pinguecula or corneal scars within the visual axis
- •Neovascularization > 0.75 mm in from the limbus
- •Giant papillary conjunctivitis (GPC) worse than Grade 1
- •Anterior uveitis or iritis (past or present)
- •Seborrheic eczema, seborrheic conjunctivitis
- •History of corneal ulcer or fungal infections
- •Poor personal hygiene
- •A known history of corneal hypoesthesia (reduced corneal sensitivity)
- •Contact Lens best corrected Snellen visual acuities (VA) worse than 20/
- •Aphakia, Keratoconus or a highly irregular cornea.
结局指标
主要结局
Comfort at Insertion
时间窗: 15 minutes
Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.
Comfort Preference
时间窗: 15 minutes
Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.
次要结局
未报告次要终点
研究者
研究点 (6)
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