NCT06161012已完成不适用
Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of Wear
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
研究概览
简要总结
This will be a multi-site, bilateral, dispensing, randomized, controlled, double-masked, 2×2 crossover study to evaluate ocular physiological response.
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
- 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.
- •The subject must:
- •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 soft 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 2 days per week during the past four weeks.
- •Possess a wearable pair of spectacles that provide correction for distance vision.
- •In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
- •Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
- •Cylinder powers (DC) -0.75 and -1.25
- •Axes (°) 170, 180, 10, 80, 90, 100
- •Have best corrected monocular distance visual acuity of 20/30 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.
- •The subject must not:
- •Be currently pregnant or lactating.
- •Be diabetic.
- •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 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.
- •Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
- •Be currently wearing monovision or multifocal contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have a history of strabismus or amblyopia.
- •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 participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •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 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).
- •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
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
时间窗: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up, 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
次要结局
未报告次要终点
研究者
研究点 (12)
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