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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:
NCT01055613
First received: January 22, 2010
Last updated: July 18, 2016
Last verified: July 2016

January 22, 2010
July 18, 2016
November 2009
May 2010   (Final data collection date for primary outcome measure)
  • Slit Lamp Findings [ Time Frame: 3 months ]
    Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.
  • Distance Visual Acuity (LogMAR) [ Time Frame: Up to 3 Months ]
    Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.
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Complete list of historical versions of study NCT01055613 on ClinicalTrials.gov Archive Site
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Investigational Multi-purpose Contact Lens Care Solution.
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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 (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Contact Lens Wear
  • Device: Vistakon Investigational Multi-Purpose Solution I
    Multi-purpose contact lens care solution.
  • Device: ReNu MultiPlus Multi-Purpose Solution
    Multi-purpose contact lens care solution
  • Experimental: Experimental multi-purpose solution
    Multi-purpose contact lens care solution.
    Intervention: Device: Vistakon Investigational Multi-Purpose Solution I
  • Active Comparator: ReNu MultiPlus Multi-Purpose Solution
    Multi-purpose 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
312
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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
 
 
NCT01055613
CR-1624
No
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Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
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Not Provided
Johnson & Johnson Vision Care, Inc.
July 2016

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