Vistakon Investigational Lens Worn as a Single Use Daily Wear
1 other identifier
interventional
50
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedResults Posted
Study results publicly available
March 17, 2011
CompletedJune 19, 2018
August 1, 2017
2 months
November 18, 2009
February 22, 2011
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (18)
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
Study Arms (2)
narafilcon B
EXPERIMENTALcontact lens
etafilcon A
ACTIVE COMPARATORcontact lens
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Salt Lake City, Utah, 84106, United States
Unknown Facility
Virginia Beach, Virginia, 23455, United States
Unknown Facility
Laramie, Wyoming, 82070, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Buch/Principal Research Optometrist
- Organization
- Vistakon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2009
First Posted
December 14, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 19, 2018
Results First Posted
March 17, 2011
Record last verified: 2017-08