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Vistakon Investigational Multi-purpose Contact Lens Care Solution.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT01055457
First received: January 22, 2010
Last updated: November 28, 2016
Last verified: November 2016

January 22, 2010
November 28, 2016
November 2009
May 2010   (Final data collection date for primary outcome measure)
  • Slit Lamp Findings (SLF) [ Time Frame: Up to 3 months Post Lens Wear ]
    Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
  • Distance Visual Acuity (LogMAR) [ Time Frame: Up to 3 Months Post Lens Wear ]
    Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.
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Complete list of historical versions of study NCT01055457 on ClinicalTrials.gov Archive Site
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Vistakon Investigational Multi-purpose Contact Lens Care Solution.
Not Provided
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Contact Lens Wear
  • Device: Vistakon Investigational Multi-Purpose Solution II
    contact lens care solution
  • Device: ReNu MultiPlus Multi-Purpose Solution
    contact lens care solution
  • Experimental: Experimental Multi-Purpose Solution
    contact lens care solution
    Intervention: Device: Vistakon Investigational Multi-Purpose Solution II
  • Active Comparator: ReNu MultiPlus Multi-Purpose Solution
    contact lens care solution
    Intervention: Device: ReNu MultiPlus Multi-Purpose Solution
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
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May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • must be an adapted contact lens wearer
  • best corrected distance visual acuity must be 20/25 or better in each eye
  • must be wearing their habitual lenses on a daily wear basis
  • must be willing to refrain from swimming during the study

Exclusion Criteria:

  • any systemic diseases that may interfere with contact lens wear
  • any clinically significant ocular disease
  • any ocular infection
  • use of certain medications
  • any grade 2 or greater slit lamp findings
  • any know sensitivity to marketed contact lens care solutions
  • currently pregnant or lactating
  • monovision corrected
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01055457
CR-1650
No
Not Provided
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Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP