Effects of Multifocal Contact Lens on Ocular Tissue

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)

Official Title
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Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: etafilcon - PVP (multi-focal)


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. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must be between 40 and 70 years of age. The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye. The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance. The subject's refractive cylinder must be less than or equal to -0.75D in each eye. The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. Subjects own a wearable pair of spectacles, if required for their distance vision. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration). The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the Presbyopic Symptoms Questionnaire. Exclusion Criteria: Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued) Any ocular or systemic allergies that contraindicate contact lens wear. Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear. Any ocular abnormality that may interfere with contact lens wear. Use of any ocular medications, with the exception of rewetting drops. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.). Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear. History of herpetic keratitis. Any ocular infection or inflammation. Any corneal distortion or irregular cornea. History of binocular vision abnormality or strabismus. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV). History of diabetes. Habitual wearer of etafilcon-A contact lens material. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Ages Eligible for Study
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Minimum Age: 40 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: etafilcon - PVP (multi-focal)<br>The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study. | Device: etafilcon - PVP (multi-focal)<br>* The investigational contact lens must be worn at least six hours daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Eye Lid Margin Staining | Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2. | 30 days Post wear | 
| Limbal Staining | Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported. | 30 Days Post Wear | 
| Corneal Staining | The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported. | 30 Days Post Wear |