A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- The Primary Effectiveness Endpoint for the Study is Monocular (Study [Right] Eye Only) Photopic Negative Lens-induced Distance-corrected Depth of Focus (DOF) at the 0.2 logMAR VA Threshold.
研究概览
简要总结
The goal of this clinical trial is to learn if the contact lens we are testing will work to extend the range of clear focus at distance to provide an increase in clear vision at closer ranges without the additional need for bifocal lenses or reading correction.
The clinical study will compare the use of the test lens for extended range of focus (far to near) to a standardized contact lens designed for distance vision (far) (ie. Walking, driving, etc., where closer-in vision is not anticipated to be helpful, particularly in a population of users in the age range of 45-70.
We will also learn about the effectiveness of the lens to maintain good contrast in low illumination such as during evening and night-time periods.
The main questions we aim to address in the study are:
*. Does the contact lens provide adequate vision at distances closer to the patient such as during reading or computer usage?
* Whether the contact lens in use introduces any visual disturbance or safety concern as compared to a currently designed lens for distance use?
The study is designed to be conducted in the doctor's office:
- Using electronic vision measuring equipment familiar to the user.
- A total of two visits are necessary to complete he study
- All patients will experience using the test lens as well as the control lens during the study
- No contâct lenses will be given to the study patients to take home.
- It is anticipated that the total amount of time of participation in the study will be approximately 3 hours of your time over two separate visits.
详细描述
The Deseyne daily disposable soft contact lens is intended for the correction of presbyopia and considered to be one of the growing class of extended depth of focus (EDOF) devices that uses a variety of strategies to provide useful intermediate and near vision. The lens is manufactured with vifilcon C material containing hyaluronic acid and tamarind seed polysaccharide, with a water content of 60% in a single diameter of 14.1 mm and base curve of 8.6 mm. The profile of the anterior surface is spherical across the 11-mm optic. Centrally, there is a 1.0 mm diameter zone that is optically inactive, contiguous with the optical zone. Light passes through the zone but is not intended to form a usable image. The central steep zone is at least 8.00 D steeper than the optical zone. The non-focusing central zone is intended to provide for an increased depth of focus, thus improving near and intermediate vision for the presbyopic patient.
Deseyne (vifilcon C) daily disposable soft contact lenses are proposed to be indicated for the optical correction of refractive ametropia (myopia and hyperopia) in non-diseased eyes with up to 1.00 D of astigmatism that does not interfere with visual acuity (VA).
A multicenter, randomized, active-controlled, double-masked, crossover study design will be used to compare the clinical performance of the Deseyne (vifilcon C) soft contact lens for Presbyopia EDOF (test) to the 1-Day Acuvue Moist (etafilcon A) soft contact lens for Single Vision (control). This is a 1-day crossover study (conducted over 2 visits) and will consist of approximately 75 subjects (75 study eyes [all study eyes will be right eyes]) randomly assigned in-office to wear the test or the control lens first. A 30-minute washout period will be scheduled between the crossover. Subjects must be otherwise healthy, with spectacle refraction between -6.00D and +4.00 D and astigmatism ≤1.00 D that does not interfere with VA.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45 to 70 years
- •Presence of clear corneas
- •Correction between -6.00 and +4.00 D in the spectacle plane
- •Phakic and/or pseudophakic subjects
- •Monocular best-corrected distance visual acuity (BCDVA) of 0.1 logMAR or better in the right eye
- •Be an adapted soft contact lens wearer in each eye
- •Able and willing to attend all scheduled sessions
- •Able to read, understand, and provide written informed consent -
排除标准
- •Anisometropia (spherical equivalent >2.00 D) in either eye
- •Ocular astigmatism >1.00 D in either eye
- •Monocular BCDVA worse than 0.3 logMAR in either eye
- •Any corneal infiltrates in either eye
- •Grade ≥2 slit lamp findings during Screening in either eye
- •Any scar or neovascularization within the central 4 mm of the cornea during Screening in either eye
- •History of ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, ocular herpes simplex or herpes zoster, etc.) within 30 days prior to Screening in either eye
- •History of gas-permeable lens wear within 30 days prior to Screening in either eye or history of "hard" contact lens wear within 3 months of Screening in either eye
- •History of any corneal surgery, including refractive or laser surgery, in either eye
- •Implantation or removal of absorbable punctal plug within 6 months of Screening in either eye or permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye
- •Use of any prescription ocular medication or any over-the-counter eyedrops within 1 week of Screening in either eye or during the period of study participation
- •Participation in any drug or device clinical investigation within 2 weeks prior to Screening or during the period of study participation
- •Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who are currently pregnant or breastfeeding
- •Systemic disease or use of any systemic medications that may, in the opinion of the Investigator, interfere with normal lens wear
研究组 & 干预措施
Test lens
Participants wear the test lens first (before crossing over to the control lens)
干预措施: Test lens (Device)
Control lens
Participants wear the control lens first (before crossing over to the test lens)
干预措施: Control lens (Device)
结局指标
主要结局
The Primary Effectiveness Endpoint for the Study is Monocular (Study [Right] Eye Only) Photopic Negative Lens-induced Distance-corrected Depth of Focus (DOF) at the 0.2 logMAR VA Threshold.
时间窗: Day 1
The primary effectiveness endpoint for the study is monocular (study \[right\] eye only) photopic negative lens-induced distance-corrected depth of focus (DOF) at the 0.2 logMAR VA threshold.. This is accomplished by adding small incremental negative lens power over the distance best corrected vision correction until blurred vision is determined (study eye only).
次要结局
- Mean Monocular (Study Eye Only) Photopic Distance-corrected Intermediate Visual Acuity (DCIVA) at 66 cm(Day 1)
- Mean Monocular (Study Eye Only) Photopic Distance-corrected Near Visual Acuity (DCNVA) at 40 cm(Day 1)