Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Study Overview
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Brief Summary
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This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.

Official Title
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Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: senofilcon A


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. Between 18 and 39 (inclusive) years of age at the time of screening. They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'. Habitual spectacles must have resulted from an eye exam within the past six months. The subject must have worn the updated spectacles for at least two weeks. Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye. The subject's refractive cylinder must be -1.00 D or less in each eye. Have spherocylindrical best corrected distance Snellen 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 Currently pregnant or lactating. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study. Use of systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics). Any current use of ocular medication. Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 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 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale. Binocular vision abnormality or strabismus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: senofilcon A<br>Subjects that are habitual spectacle wearers that have never worn contact lenses and have had an eye exam and an updated spectacle prescription in the last 6 months will be enrolled and fitted into the senofilcon A TEST Lens for a total period of 4 weeks. | Device: senofilcon A<br>* TEST Lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable Lens Fitting | Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling. | 4-Week Follow-up |