Vistakon Investigational Lens Worn as a Single Use Daily Wear

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01031004
• Other study ID #: CR-1655
• Status: Completed
• Phase: N/A
• Start date: October 1, 2009
• Est. completion date: December 1, 2009

Study information

• Verified date: August 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2009
• Est. primary completion date: December 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• narafilcon B
contact lens
• etafilcon A
contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Average Wear Time		after 1 week of lens wear
Primary	Average Wear Time		after 1 month of lens wear