Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 8
- 主要终点
- Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
研究概览
简要总结
The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]).
- •Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- •Between 35 and 47 years of age (inclusive).
- •Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
- •Refractive astigmatism of 0.75D or less in both eyes.
- •Visual symptoms associated with near vision
- •Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
- •Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection.
- •No conjunctival abnormality or infection.
- •No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
- •No other active ocular disease.
排除标准
- •Monovision user or multifocal CL wearer.
- •Regular user of reading spectacles (i.e. daily usage).
- •Requires concurrent ocular medication.
- •Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
- •Corneal staining Grade 3 in more than two regions.
- •Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
- •Pre-existing ocular irritation that would preclude CL fitting.
- •Keratoconus or other corneal irregularity.
结局指标
主要结局
Subject Reported Overall Vision Quality Using (CLUE)TM Questionnaire
时间窗: week 4
The Contact Lens User Experience (CLUE) Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with scores ranging from 0-120.
Monocular Amplitude of Accommodation
时间窗: week 4
The amplitude of accommodation is a measure of the eyes ability to accommodate or focus on near objects. The method used was the push-up/push-down method performed monocularly. One eye was occluded and using the smallest print the subject was able to read, the reading chart was slowly moved towards the subject. The subject was asked them to indicate when the print first becomes blurred. The distance was noted and the amplitude of accommodation was calculated.
次要结局
- Comfortable Wearing Time(week 4)
- Proportion of Subjects With Near Vision Symptoms as Assessed by the NVQ(week 4)
- Subject Reported Lens Comfort Using CLUE Questionnaire(week 4)
- Proportion of Subjects Benefiting From the Binocular +/-1.00D Accommodative Flipper(Baseline)