Clinical Study of Approved and Investigational Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 17
- 主要终点
- Frequency of Lens Awareness Individual Item
研究概览
简要总结
This is a multi-site, 5-visit, double-masked, dispensing study comparing an investigational contact lens with currently-marketed contact lenses. The objective of the study is to evaluate the comfort of the lenses when worn for 30 (-2/+6) days on daily wear modality.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 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 18 to 40 years of age at the time of consent.
- •The subject's spherical equivalent distance refraction must be in the range of -1.25 to -6.00 in each eye.
- •The subject's refractive cylinder must be ≤1.00D in each eye.
- •The subject must have best corrected visual acuity of 20/30 or better in each eye.
- •The subject must be a habitual frequent replacement (reusable) daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
- •The subject must be able to wear contact lenses for a minimum of 8 hours, 4 days per week.
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
- •Any daily disposable, extended wear, monovision, toric or multi-focal contact lens correction.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- •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.
- •Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV), by self-report).
- •Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
研究组 & 干预措施
Senofilcon C Wearers
Senofilcon C Wearers will wear the Senofilcon C Contact Lenses as daily wear for 30 (-2/+6) days.
干预措施: Senofilcon C Contact Lens (Device)
Comfilcon A Wearers
Comfilcon A Wearers will wear the Comfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
干预措施: Comfilcon A Contact Lens (Device)
Lotrafilcon B Wearers
Lotrafilcon B Wearers will wear the Lotrafilcon B Contact Lens as daily wear for 30 (-2/+6) days.
干预措施: Lotrafilcon B Contact Lens (Device)
Samfilcon A Wearers
Samfilcon A Wearers will wear the Samfilcon A Contact Lens as daily wear for 30 (-2/+6) days.
干预措施: Samfilcon A Contact Lens (Device)
结局指标
主要结局
Frequency of Lens Awareness Individual Item
时间窗: 1 month Follow-up
Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Subjective Overall Comfort Composite Score
时间窗: Up to 1 month Follow-up
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.
Overall Comfort Individual Item
时间窗: 1 month follow-up
Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Comfort at the End of the Day Individual Item
时间窗: 1 month Follow-up
Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Comfort Each and Everyday Individual Item
时间窗: 1 month Follow-up
Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
Frequency of Experiencing Dryness Individual Item
时间窗: 1 month Follow-up
Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.
Making Your Eyes Feel Moist Throughout the Day Individual Item
时间窗: Up to 1 month Follow-up
Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.
次要结局
- Overall Opinion Individual Item(Up to 1 month Follow-up)
- Subjective Overall Quality of Vision Composite Score(Up to 1 month Follow-up)
- Overall Quality of Vision Individual Item(Up to 1 month Follow-up)