Vistakon Investigational Lens Worn as a Single Use Daily Wear

Study Overview
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Brief Summary
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This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.

Conditions
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Myopia

Intervention / Treatment
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* Device: narafilcon B
* Device: etafilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: eyes must be best-corrected to a visual acuity of 20/30 or better in each eye must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study distance spherical contact lens prescription must be within the range available for the study Exclusion Criteria: systemic diseases which may interfere with contact lens wear ocular infection or clinically significant ocular disease any previous intraocular surgery grade 2 or greater slit lamp findings currently pregnant or lactating more than 1.00D of refractive astigmatism in either eye

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: narafilcon B<br>contact lens | Device: narafilcon B<br>* contact lens<br>|
| Active Comparator: etafilcon A<br>contact lens | Device: etafilcon A<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings - Corneal Edema | Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit. | after 1 week of lens wear | 
| Corneal Edema at Month 1 | Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. | after 1 month of lens wear | 
| Slit Lamp Findings - Corneal Neovascularization | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. | after 1 week of lens wear | 
| Slit Lamp Findings - Corneal Neovascularization | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit. | after 1 month of lens wear | 
| Slit Lamp Findings - Corneal Staining | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit. | after 1 week of lens wear | 
| Slit Lamp Findings - Corneal Staining | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit. | after 1 month of lens wear | 
| Slit Lamp Findings - Injection | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. | after 1 week of lens wear | 
| Slit Lamp Findings - Injection | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit. | after 1 month of lens wear | 
| Slit Lamp Findings - Tarsal Abnormalities | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. | after 1 week of lens wear | 
| Slit Lamp Findings - Tarsal Abnormalities | Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit. | after 1 month of lens wear | 
| Slit Lamp Findings - Infiltrates | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. | after 1 week of lens wear | 
| Slit Lamp Findings - Infiltrates | Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit. | after 1 month of lens wear | 
| Subject Reported Symptoms | Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear. | after 1 week of lens wear | 
| Subject Reported Symptoms | Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear. | after 1 month of lens wear | 
| Visual Acuity (VA) | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit. | after 1 week | 
| Visual Acuity (VA) | Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit. | after 1 month | 
| Average Wear Time |  | after 1 week of lens wear | 
| Average Wear Time |  | after 1 month of lens wear |