Vistakon Investigational Lens Worn as a Single Use Daily Wear
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 50
- Primary Endpoint
- Visual Acuity (VA)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Visual Acuity (VA)
Time Frame: 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
Time Frame: 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
Time Frame: 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 - Infiltrates
Time Frame: 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.
Slit Lamp Findings - Tarsal Abnormalities
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Average Wear Time
Time Frame: after 1 month of lens wear
Slit Lamp Findings - Corneal Edema
Time Frame: 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
Time Frame: after 1 month of lens wear
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.