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Completed

NCT Number: NCT01031004

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.

Completed

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salt Lake City, Utah, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

narafilcon B

Device

contact lens

etafilcon A

Device

contact lens

Primary outcomes

  1. Slit Lamp Findings - Corneal Edema

    Time frame: after 1 week of lens wear

    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.

  2. Corneal Edema at Month 1

    Time frame: after 1 month of lens wear

    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.

  3. Slit Lamp Findings - Corneal Neovascularization

    Time frame: after 1 week of lens wear

    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.

  4. Slit Lamp Findings - Corneal Neovascularization

    Time frame: after 1 month of lens wear

    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.

  5. Slit Lamp Findings - Corneal Staining

    Time frame: after 1 week of lens wear

    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.

  6. Slit Lamp Findings - Corneal Staining

    Time frame: after 1 month of lens wear

    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.

  7. Slit Lamp Findings - Injection

    Time frame: after 1 week of lens wear

    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.

  8. Slit Lamp Findings - Injection

    Time frame: after 1 month of lens wear

    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.

  9. Slit Lamp Findings - Tarsal Abnormalities

    Time frame: after 1 week of lens wear

    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.

  10. Slit Lamp Findings - Tarsal Abnormalities

    Time frame: after 1 month of lens wear

    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.

  11. Slit Lamp Findings - Infiltrates

    Time frame: after 1 week of lens wear

    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.

  12. Slit Lamp Findings - Infiltrates

    Time frame: after 1 month of lens wear

    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.

  13. Subject Reported Symptoms

    Time frame: after 1 week of lens wear

    Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.

  14. Subject Reported Symptoms

    Time frame: after 1 month of lens wear

    Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.

  15. Visual Acuity (VA)

    Time frame: after 1 week

    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.

  16. Visual Acuity (VA)

    Time frame: after 1 month

    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.

  17. Average Wear Time

    Time frame: after 1 week of lens wear

  18. Average Wear Time

    Time frame: after 1 month of lens wear

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 14, 2009
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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