Clinical Evaluation of Investigational Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Visual Performance (LogMar)
研究概览
简要总结
Single-visit, unmasked, non-dispensing study where subjects will wear three different lenses bilaterally in one visit, each lens being worn for approximately 30-60 minutes. Subjects will complete a questionnaire for each study lens.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be at least 18 years of age and no more than 55 years of age (inclusive).
- •The subject's vertex corrected best spherical distance refraction must be in the range of -1.00 to -6.00 Diopters (D) in each eye.
- •The subject's vertex corrected cylindrical component of distance refraction must be less than or equal to -1.50 Diopters of Cylinder (DC) in each eye.
- •Subjects must have best corrected visual acuity of 20/25 (Snellen or equivalent) or better in each eye.
- •Subjects must self-report as being Asian race.
- •Subjects must self-report as having brown or black eyes.
- •Subjects must be habitual lens wearer (clear or limbal ring cosmetic) . Habitual is defined as at least one (1) month of Contact Lens wear where the lenses were worn for a minimum of six (6) hours per day and a minimum of three (3) days per week.
- •Subjects between 18 to 39 years old must be habitual limbal ring cosmetic lens wearers or must have tried limbal ring cosmetic lens within the past two years.
- •Subjects must be cosmetic contact lens concept acceptors as determined by screening questionnaire.
- •Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigator's discretion).
- •Subjects must read, understand, and sign the Statement of Informed Consent.
- •Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- •Subjects must be willing to have their eyes video recorded and photographed.
排除标准
- •Working for any advertising agency, any company involved in public relations or marketing, market research; or any company that makes or sells contact lenses or glasses.
- •Participated in any paid market research within the past 3 months.
- •Pregnant or breast feeding a baby.
- •Subjects with diabetes.
- •Any ocular or systemic allergies or disease which might interfere with contact lens wear.
- •Any systemic disease, or autoimmune disease, which might interfere with contact lens wear, at investigator's discretion.
- •Using medications during and immediately preceding the study period that may interfere with current contact lens wear as determined by the investigators
- •Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- •Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.
- •Any active ocular abnormalities/conditions that might interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection etc.).
- •Any corneal distortion, scar, or opacity affecting vision as noted by subjects or investigators during examination.
- •History of any corneal surgery (e.g. radial keratotomy (RK), photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK)); confirmed with topography if necessary at the investigator's discretion.
- •Habitual wearers of rigid gas permeable or orthokeratology lens within the past 3 months.
- •Current habitual contact lens modality for extended wear or conventional wear (contact lenses with a replacement schedule of 3 months to >1 year).
- •Participation in any pharmaceutical, medical device, or contact lens related clinical research trial within 14 days prior to study enrollment. This excludes studies that do not require product treatment/intervention.
结局指标
主要结局
Visual Performance (LogMar)
时间窗: 30 Minutes Post Insertion
Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.
CLUE Handling
时间窗: 30 Minutes Post Insertion
CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).
Percentage of Eyes With Acceptable Mechanical Lens Fit
时间窗: 30 Minutes Post Insertion
Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.
Percentage of Eyes With Acceptable Cosmetic Lens Fit
时间窗: 30 Minutes Post Insertion
Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.
次要结局
未报告次要终点