Clinical Performance Comparison of Several Different Contact Lenses

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.

Official Title
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Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: senofilcon A
* Device: lotrafilcon B
* Device: balafilcon A
* Device: methafilcon A
* Device: vifilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must: be existing soft contact lens wearers of the study control lenses require a distance visual correction in both eyes have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes have astigmatism less than or equal to 1.00D in both eyes be able to wear lenses available for this study be corrected to a visual acuity of 6/9 (20/30) or better in each eye have normal eyes with no evidence of abnormality or disease Exclusion Criteria: Subject are excluded for the following reasons: monovision corrected worn lenses extended wear in the last 3 months. require concurrent ocular medication grade 3 or 4 abnormalities grade 3 corneal staining in more than two regions anterior ocular surgery any other ocular surgery or injury within 8 weeks prior to study enrollment abnormal lachrymal secretions pre-existing ocular irritation that would preclude contact lens fitting corneal irregularities Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks any systemic illness which would preclude contact lens wear diabetes infectious or immunosuppressive disease pregnancy or lactating, or planning pregnancy at time or enrollment participating in a concurrent clinical study or within last 60 days allergy to the standardized study care solution

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilcon A<br>contact lens | Device: senofilcon A<br>* contact lens<br>|
| Active Comparator: lotrafilcon B<br>contact lens | Device: lotrafilcon B<br>* contact lens<br>|
| Active Comparator: balafilcon A<br>contact lens | Device: balafilcon A<br>* contact lens<br>|
| Active Comparator: methafilcon A<br>contact lens | Device: methafilcon A<br>* contact lens<br>|
| Active Comparator: vifilcon A<br>contact lens | Device: vifilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limbal Hyperemia (Redness) | Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 2 weeks | 
| Limbal Hyperemia (Redness) | Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 4 weeks | 
| Bulbar Hyperemia (Redness) | Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 2 weeks | 
| Bulbar Hyperemia (Redness) | Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 4 weeks | 
| Corneal Staining | Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 2 weeks | 
| Corneal Staining | Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted. | 4 weeks |