NCT07819305尚未招募不适用
Evaluation of Approved Contact Lenses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Binocular High Luminance, Low Contrast (HLLC) Distance (4 meters) Visual Acuity (logMAR) at 2-week Follow-up
研究概览
简要总结
This is a prospective, multi-site, bilateral, 2-week dispensing, randomized, controlled, single-masked (subjects), 2x2 crossover study to evaluate visual acuity.
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
- Single (Participant)
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
- •at baseline evaluation
- •The vertex corrected subjective best sphere distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
- •The magnitude of the cylindrical component of the subject's vertex corrected distance refraction must be less than or equal to 1.00 D (inclusive) in each eye with any degree of axis.
- •The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Be currently pregnant or lactating.
- •Be diabetic.
- •Have any current ocular infection of any type.
- •Be currently using any ocular medications. The use of topical ophthalmic allergy medications may be acceptable provided the medication regimen has remained stable for at least 14 days prior to enrollment and is expected to remain unchanged throughout study participation. All ophthalmic medications must be administered according to the approved product labeling, including any instructions regarding contact lens removal and reinsertion. Any changes in medication type, dose, frequency, duration, or administration instructions during the study will be documented and may result in a protocol deviation or study discontinuation.
- •Routinely require or use artificial tears, lubricant eye drops, or contact lens rewetting drops for successful contact lens wear. Subjects with occasional, non-routine use may be enrolled provided they self-report discontinuation prior to enrollment and agree to refrain from their use during the study. Use of artificial tears, lubricant eye drops, or contact lens rewetting drops during a study lens wear period is not permitted. Any such use during the study will be documented and may result in a protocol deviation or study discontinuation.
- •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.
- •Have habitually worn rigid gas permeable (RGP) contact lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
- •Be currently wearing monovision, multifocal, or toric soft contact lenses.
- •Be currently wearing lenses in an extended wear modality.
- •Have a self-reported history of allergy, hypersensitivity, or intolerance to any study product or ancillary supply that, in the Investigator's judgment, could interfere with study participation or evaluation of study endpoints.
- •Have participated in a contact lens or lens care product trial within 14 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 might 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 strabismus (constant or intermittent) or amblyopia.
- •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 that may impact contact lens wear or study participation (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
排除标准
- 未提供
研究组 & 干预措施
Test/Control
Experimental
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Control lens for approximately 2 weeks.
干预措施: Test (Senofilcon A) (Device)
Test/Control
Experimental
Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Control lens for approximately 2 weeks.
干预措施: Control (Serafilcon A) (Device)
Control/Test
Experimental
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Test lens for approximately 2 weeks.
干预措施: Test (Senofilcon A) (Device)
Control/Test
Experimental
Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Test lens for approximately 2 weeks.
干预措施: Control (Serafilcon A) (Device)
结局指标
主要结局
Binocular High Luminance, Low Contrast (HLLC) Distance (4 meters) Visual Acuity (logMAR) at 2-week Follow-up
时间窗: At 2-week follow-up
次要结局
未报告次要终点
研究者
研究点 (8)
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