Clinical Evaluation of Two Approved Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 26
- 主要终点
- Overall Quality of Vision
研究概览
简要总结
Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact 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
- 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
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be between (and including) 18 and 39 years of age.
- •The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
- •Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
- •Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
排除标准
- •Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any autoimmune disease or use of medication, which may interfere with contact lens wear.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- •Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Monovision, multi-focal, toric, or extended wear contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
结局指标
主要结局
Overall Quality of Vision
时间窗: 7-Day Follow-up
Overall quality of vision 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
Overall Comfort
时间窗: 7-Day Follow-up
Overall 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.
次要结局
- Individual Patient Reported Outcomes (Items 6-10)(7-Day Follow-up)
- Individual Patient Reported Outcomes (Items 11-14)(7-Day Follow-up)
- Individual Patient Reported Outcomes (Items 15-17)(7-Day Follow-up)
- Individual Patient Reported Outcomes (Items 1-5)(7-Day Follow-up)