NCT05361304已完成不适用
Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 12
- 主要终点
- Average Daily Wearing Time
研究概览
简要总结
This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be between 18 and 39 (inclusive) years of age at the time of screening.
- •By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
- •Possess a wearable pair of spectacles that provide correction for distance vision.
- •The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
- •The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
- •The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or lactating.
- •Be currently using any ocular medications or have any ocular infection of any type.
- •By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
- •Be currently wearing monovision or multifocal contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- •Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes will contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed).
- •Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- •Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
结局指标
主要结局
Average Daily Wearing Time
时间窗: 2-Week Follow-up
Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.
Monocular logMAR Visual Acuity
时间窗: 2-Week Follow-up
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
次要结局
- CLUE Comfort Score(2-Week Follow-up)
- CLUE Vision Score(2-Week Follow-up)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing TechnologyVisual AcuityNCT04531241Johnson & Johnson Vision Care, Inc.136
终止
不适用
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding ProcessRefractive Error CorrectionNCT03605303Johnson & Johnson Vision Care, Inc.3
已完成
不适用
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2MyopiaNCT03701516Johnson & Johnson Vision Care, Inc.268
已完成
不适用
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing TechnologyVisual AcuityNCT03962790Johnson & Johnson Vision Care, Inc.95
已完成
不适用
The Clinical Comparison of Senofilcon A and Stenfilcon A Contact LensesMyopiaNCT02643004Coopervision, Inc.70