Back to resultsVistakon Investigational Lens Worn as a Single Use Daily Wear
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
narafilcon B
etafilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
narafilcon B
etafilcon A
Arm Description
contact lens
contact lens
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Subject Reported Symptoms
Number of eyes in which subjects reported lens-related symptoms 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.
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.
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.
Average Wear Time
Average Wear Time
Secondary Outcome Measures
Full Information
NCT ID
NCT01031004
First Posted
November 18, 2009
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01031004
Brief Title
Vistakon Investigational Lens Worn as a Single Use Daily Wear
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
narafilcon B
Arm Type
Experimental
Arm Description
contact lens
Arm Title
etafilcon A
Arm Type
Active Comparator
Arm Description
contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon B
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
etafilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Slit Lamp Findings - Corneal Edema
Description
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.
Time Frame
after 1 week of lens wear
Title
Corneal Edema at Month 1
Description
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.
Time Frame
after 1 month of lens wear
Title
Slit Lamp Findings - Corneal Neovascularization
Description
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.
Time Frame
after 1 week of lens wear
Title
Slit Lamp Findings - Corneal Neovascularization
Description
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.
Time Frame
after 1 month of lens wear
Title
Slit Lamp Findings - Corneal Staining
Description
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.
Time Frame
after 1 week of lens wear
Title
Slit Lamp Findings - Corneal Staining
Description
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.
Time Frame
after 1 month of lens wear
Title
Slit Lamp Findings - Injection
Description
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.
Time Frame
after 1 week of lens wear
Title
Slit Lamp Findings - Injection
Description
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.
Time Frame
after 1 month of lens wear
Title
Slit Lamp Findings - Tarsal Abnormalities
Description
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.
Time Frame
after 1 week of lens wear
Title
Slit Lamp Findings - Tarsal Abnormalities
Description
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.
Time Frame
after 1 month of lens wear
Title
Slit Lamp Findings - Infiltrates
Description
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.
Time Frame
after 1 week of lens wear
Title
Slit Lamp Findings - Infiltrates
Description
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.
Time Frame
after 1 month of lens wear
Title
Subject Reported Symptoms
Description
Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Time Frame
after 1 week of lens wear
Title
Subject Reported Symptoms
Description
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Time Frame
after 1 month of lens wear
Title
Visual Acuity (VA)
Description
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.
Time Frame
after 1 week
Title
Visual Acuity (VA)
Description
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.
Time Frame
after 1 month
Title
Average Wear Time
Time Frame
after 1 week of lens wear
Title
Average Wear Time
Time Frame
after 1 month of lens wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82070
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vistakon Investigational Lens Worn as a Single Use Daily Wear
We'll reach out to this number within 24 hrs