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Vistakon Investigational Lens Worn as a Single Use Daily Wear

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ClinicalTrials.gov Identifier: NCT01031004
Recruitment Status : Completed
First Posted : December 14, 2009
Results First Posted : March 17, 2011
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Myopia Device: narafilcon B Device: etafilcon A Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : October 1, 2009
Actual Primary Completion Date : December 1, 2009
Actual Study Completion Date : December 1, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Experimental: narafilcon B
contact lens
Device: narafilcon B
contact lens
Active Comparator: etafilcon A
contact lens
Device: etafilcon A
contact lens



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031004


Locations
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Virginia
Virginia Beach, Virginia, United States, 23455
United States, Wyoming
Laramie, Wyoming, United States, 82070
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01031004     History of Changes
Other Study ID Numbers: CR-1655
First Posted: December 14, 2009    Key Record Dates
Results First Posted: March 17, 2011
Last Update Posted: September 29, 2017
Last Verified: August 2017