Vistakon Investigational Lens Worn as a Single Use Daily Wear
- Conditions
- Myopia
- Interventions
- Device: narafilcon BDevice: etafilcon A
- Registration Number
- NCT01031004
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description narafilcon B narafilcon B contact lens etafilcon A etafilcon A contact lens
- Primary Outcome Measures
Name Time Method Visual Acuity (VA) after 1 month 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.
Corneal Edema at Month 1 after 1 month of lens wear 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.
Slit Lamp Findings - Corneal Neovascularization after 1 month of lens wear 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.
Slit Lamp Findings - Tarsal Abnormalities after 1 month of lens wear 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.
Slit Lamp Findings - Corneal Staining after 1 month of lens wear 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.
Slit Lamp Findings - Injection after 1 month of lens wear 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.
Slit Lamp Findings - Infiltrates after 1 month of lens wear 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.
Average Wear Time after 1 month of lens wear Slit Lamp Findings - Corneal Edema after 1 week of lens wear 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.
Subject Reported Symptoms after 1 month of lens wear Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
- Secondary Outcome Measures
Name Time Method