Vistakon Investigational Lens Worn as a Single Use Daily Wear - Full Text View

Purpose

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.

Condition	Intervention
Myopia	Device: narafilcon B Device: etafilcon A

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Edema Eye Wear

U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:

Slit Lamp Findings - Corneal Edema [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
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 week of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
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 week of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
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 [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: Yes ]
Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.
Subject Reported Symptoms [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: Yes ]
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
Visual Acuity (VA) [ Time Frame: after 1 week ] [ Designated as safety issue: No ]
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) [ Time Frame: after 1 month ] [ Designated as safety issue: No ]
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 [ Time Frame: after 1 week of lens wear ] [ Designated as safety issue: No ]
Average Wear Time [ Time Frame: after 1 month of lens wear ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	October 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: narafilcon B contact lens	Device: narafilcon B contact lens
Active Comparator: etafilcon A contact lens	Device: etafilcon A contact lens

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01031004

Locations

United States, Utah

Salt Lake City, Utah, United States, 84106
United States, Virginia

Virginia Beach, Virginia, United States, 23455
United States, Wyoming

Larimie, Wyoming, United States, 82070

Sponsors and Collaborators

Vistakon

More Information

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT01031004 History of Changes
Other Study ID Numbers:	CR-1655
Study First Received:	November 18, 2009
Results First Received:	February 22, 2011
Last Updated:	October 10, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 13, 2013