Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

Study Overview
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Brief Summary
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This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Official Title
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Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE® OASYS 1-DAY
* Device: ACUVUE® OASYS 1-DAY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening. The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear). The subject must have normal eyes (i.e., no ocular medications or infections of any type). The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye. The subject's refractive cylinder must be ≤0.75D in each eye, if present The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator) Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Monovision or multi-focal contact lens correction. 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). Suspicion of or recent history of alcohol or substance abuse. History of serious mental illness. History of seizures. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician) 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 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Control<br>Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Test/Control. | Device: ACUVUE® OASYS 1-DAY<br>* senofilcon A contact lenses made with a novel manufacturing technology<br>* Other names: TEST;Device: ACUVUE® OASYS 1-DAY<br>* senofilcon A contact lenses made with the current manufacturing technology<br>* Other names: CONTROL;|
| Experimental: Control/Test<br>Eligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Control/Test. | Device: ACUVUE® OASYS 1-DAY<br>* senofilcon A contact lenses made with a novel manufacturing technology<br>* Other names: TEST;Device: ACUVUE® OASYS 1-DAY<br>* senofilcon A contact lenses made with the current manufacturing technology<br>* Other names: CONTROL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall CLUE Comfort | 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. | 1-Week Follow-up | 
| Overall CLUE Vision | Overall 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. | 1-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Performance | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under both high luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For high illumination, the room was required to be >400 lux with low contrast charts. For low illumination, the room was required to be <2.5 lux. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. | 1-Week Follow-up | 
| Average Daily Wear Time (in Hours) | Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow up evaluation. | 1-Week Follow-up |