Vistakon Investigational Lens Worn as a Single Use Daily Wear

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: etafilcon A; Device: narafilcon B

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
  • Virginia
    • Virginia Beach, Virginia, United States, 23455
  • Wyoming
    • Laramie, Wyoming, United States, 82070

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: narafilcon B; contact lens	Device: narafilcon B; contact lens
Active Comparator: etafilcon A; contact lens	Device: etafilcon A; contact lens

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 14, 2009

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-1655