A Randomized, Active-Controlled, Open-Label Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye
研究概览
简要总结
This clinical study is to provide clinical performance data comparing the test lens (Deseyne [vifilcon C] daily disposable soft contact lens) to a control lens (1-Day Acuvue Moist [etafilcon A] daily disposable soft contact lens) in the same indication for use (single use prior to removal followed by a fresh lens upon the next lens wear exposure). The study is designed to test the hypothesis that the test lens is substantially equivalent to the control lens in like indications for use.
详细描述
A multicenter, randomized, active-controlled, open-label study design will be used to compare the clinical performance of the Deseyne (vifilcon C) test soft contact lens to the similarly indicated 1-Day Acuvue® Moist® (etafilcon A) control soft contact lens.
Study participation is approximately 90 days in duration and will consist of approximately 80 subjects assigned in a 2:1 ratio to test or control lens bilaterally, respectively. Subjects must be otherwise healthy, with myopia between -1.00 D and -6.00 D and astigmatism no greater than 1.00 D that does not interfere with VA.
At the Screening Visit, approximately two-thirds of the eligible subjects will be randomized to receive the test lens (Deseyne [vifilcon C] lenses) and the other one-third eligible subjects will be randomized to receive the control lens (1-Day Acuvue Moist [etafilcon A] lenses). At the Dispensing Visit (Visit 2), subjects will be provided with test or control lenses as part of the dispensing package, along with instructions for the use and care of the lenses. They will be recommended unpreserved lubricating/rewetting solution for use as needed during the study.
Subjects will wear their assigned lenses bilaterally on a daily wear basis, for a minimum of 6 hours/day throughout the study (no maximum time is mandated, as long as subjects do not sleep in their lenses), with additional visits planned for 1 Week (Visit 3), 1 Month (Visit 4), 2 Months (Visit 5), and 3 Months/Exit Visit (Visit 6).
This study follows United States Food and Drug Administration (FDA) Premarket Notification 510(k) Guidance for Daily Wear Contact Lenses adopted in May 1994, and any unpublished subsequent policy declarations.
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
- None
盲法说明
Open label randomization assignment between test and control intervention.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 40 years of age on the date the informed consent form (ICF) is signed
- •Presence of clear central corneas and absence of any anterior segment disorders in each eye
- •Presence of myopia and requirement for lens correction from -1.00 D to -6.00 D in each eye
- •Best-corrected distance visual acuity (BCDVA) of 50 ETDRS letters (0.1 logMAR) or better in each eye
- •Be an adapted soft contact lens wearer in each eye and agree to wear study lenses in each eye on a daily wear basis and not wear a non-study lens for approximately 3 months
- •Able and willing to comply with all treatment and follow-up/study procedures
- •Able to read, understand, and provide written informed consent on the IRB-approved ICF and provide authorization as appropriate for local privacy regulations
排除标准
- •Participation in any drug or device clinical investigation within 2 weeks prior to Screening and/or during the period of study participation
- •Women of childbearing potential (those who are not surgically sterilized or postmenopausal) who meet any of the following conditions:
- •Currently pregnant
- •Plans to become pregnant during the study
- •Currently breastfeeding
- •History of gas permeable lens wear in either eye within 30 days prior to Screening or history of polymethylmethacrylate lens wear in either eye within 3 months prior to Screening
- •Current monovision, multifocal, or toric contact lens wear in either eye
- •In either eye, current nonabsorbable punctal plug or implantation of absorbable punctal plug within 2 to 6 months (depending on type of absorbable plug) prior to Screening, or punctal plug removal within 2 months prior to Screening. Permanent punctal occlusion in 1 or more puncta or nasolacrimal duct obstruction in either eye is excluded
- •Use of any prescription ocular medication throughout the duration of the study. Prescription eyedrops for dry eye disease (eg, Restasis, Xiidra, Cequa, Eysuvis), as well as nasally administered Tyrvaya, must be discontinued 2 weeks prior to Screening and are prohibited throughout the duration of the study Clinical Study Protocol Version 3.0, 26 April 2023 Page 17 of 66 Bruno Vision Care Protocol 22001
- •Use of over-the-counter eyedrops (eg, oxymetazoline, naphazoline, ketotifen, etc.), except for unpreserved lubricant eyedrops or artificial tears (eg, Systane, Refresh), within 1 week prior to Screening and throughout the duration of the study
- •Use of any systemic or topical medications that may, in the Investigator's opinion, affect ocular physiology or lens performance
- •Anisometropia (spherical equivalent) >2.00 D
- •Ocular astigmatism >1.00 D in either eye
- •Amblyopia in either eye
- •Aphakia in either eye
- •Active ocular disease (eg, dry eye disease, blepharitis, conjunctivitis, keratitis, etc.) in either eye. Subjects must be symptom free for at least 7 days
- •History or evidence of ocular infection within 30 days prior to Screening
- •History or evidence of ocular herpes simplex or ocular herpes zoster
- •Any grade corneal infiltrates in either eye
- •Grade ≥2 finding in either eye during slit lamp examination
- •Any "Present" finding in either eye during slit lamp examination that, in the Investigator's opinion, may interfere with contact lens wear
- •Any scar or neovascularization within the central 4 mm of the cornea in either eye. Subjects with minor peripheral corneal scarring (not extending into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible to participate in this study
- •History of any corneal surgery (eg, refractive surgery or therapeutic) in either eye
- •Any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study
- •Allergy to any component in the study care products
- •Meet any of the following criteria:
- •Subject is an employee of the investigative site
- •Subject or a member of the subject's household is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician
- •Subject or a member of the subject's household is an employee of a manufacturer of contact lenses or contact lens care products
- •Subject or a member of the subject's household is an employee of a market research firm -
结局指标
主要结局
Change From Baseline to Each Post-Baseline Visit in Distance logMAR Visual Acuity (Letters Read) by Eye
时间窗: Baseline, Day 1, Week 1, Month 1, Month 2, Month 3
To assess each eye for the change from baseline to each post-baseline visit in distance logMAR VA (letters read)
Number and Percentage of Subjects With No More Than 5 Letters Read Loss From Baseline
时间窗: Day 1, Week 1, Month 1, Month 2, Month 3
To assess the number and percentage of subjects with no more than 5 letters read loss from baseline
Slit Lamp Findings Grade >2 at Any Follow-Up Visit
时间窗: 3 months
To assess the following slit lamp findings: epithelial edema, epithelial microcysts, limbal injection, bulbar injection, upper lid tarsal conjunctival, corneal neovascularization, and corneal infiltrates
次要结局
- Symptoms/Complaints(Month 3)
- Lens Wettability, Centration, and Movement(3 months)
- Lens Deposits(3 months)