Clinical Evaluation of Etafilcon 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 both Test and Control lenses in each eye 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 Etafilcon A Contact Lenses Using a Novel Manufacturing Technology

Conditions
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Visual Acuity

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 hydrogel daily disposable brand 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 -6.00 D in each eye. The subject's refractive cylinder must be < 0.75D in each eye. The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 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. 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 14 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 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.

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 hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test). | Device: 1-DAY ACUVUE® MOIST<br>* etafilcon A contact lenses made with a new manufacturing technology<br>* Other names: Test;Device: 1-DAY ACUVUE® MOIST<br>* etafilcon A contact lenses made with the current manufacturing technology<br>* Other names: Control;|
| Experimental: Control/Test<br>Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test). | Device: 1-DAY ACUVUE® MOIST<br>* etafilcon A contact lenses made with a new manufacturing technology<br>* Other names: Test;Device: 1-DAY ACUVUE® MOIST<br>* etafilcon 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 Comfort Score | Overall comfort score 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 (standard deviation [SD] 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. | 1-Week Follow-up | 
| Overall Vision Score | 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. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. | 1-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LogMAR Visual Performance Scale | Visual acuity measured via Early Treatment Diabetic Retinopathy Study (ETDRS) charts (logMAR) can take on any possible value. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance is reported for each lens type on high contrast dim light and low contrast bright light. | 1-Week follow-up | 
| Average Daily Wear Time | Average daily wear time was calculated as the number of hours between participants 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 |