Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

Study Overview
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Brief Summary
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The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.

Official Title
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Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

Conditions
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Vision Correction

Intervention / Treatment
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* Device: Multifocal Test Contact lens


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 to +2.00 in each eye. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye. The subject's ADD power must be in the range of +0.75 D to +2.50. 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 ocular or systemic allergies that contraindicate contact lens wear. Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear. Any ocular abnormality that may interfere with contact lens wear. Use of any ocular medication, 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. Current or previous history of being prescribed a correction for distance vision. Current or previous history of contact lens wear. 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal Test Contact Lens<br>Subjects will wear the test lenses at least six hours per day, at least five days per week | Device: Multifocal Test Contact lens<br>* Used in a daily wear modality<br>* Other names: etafilcon A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Successful Contact Lens Wearers | Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, Overall Quality of Vision and Overall Comfort. Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded Excellent, Very Good or Good then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers. | 2 months post wear |