NCT04849780已完成不适用
Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 18
- 主要终点
- Change From Baseline Comfort Score
研究概览
简要总结
This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 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.
- •Between 18 and 59 (inclusive) years of age at the time of screening.
- •Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report.
- •Have a CLDEQ-8 score of 15 or greater with the habitual lens.
- •Subjects must possess a pair of spectacles for distance correction.
- •Subject's habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision® MyDay®, or Johnson & Johnson 1-Day ACUVUE® Moist.
- •The subject's vertex corrected spherical distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
- •The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye.
- •Have spherical best corrected visual acuity of 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:
- •Subject's habitual lens is ACUVUE OASYS®1-Day.
- •Currently pregnant or lactating, by self-report.
- •Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- •Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- •Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
- •Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal.
- •. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
- •Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
- •Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (Rx or over the counter (OTC)) that may interfere with contact lens wear (at the discretion of the investigator).
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •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.
结局指标
主要结局
Change From Baseline Comfort Score
时间窗: Up to 2-Week Follow-up
Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.
次要结局
- CLDEQ-8 Score(2-Week Follow-up)
- Comfort Score(2-Week Follow-up)
- Change From Baseline CLDEQ-8 Score(Up to 2-Week Follow-up)
研究者
研究点 (18)
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