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Vistakon Investigational Multi-purpose Contact Lens Care Solution.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055457
First Posted: January 25, 2010
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
January 22, 2010
January 25, 2010
August 10, 2016
January 24, 2017
September 19, 2017
November 1, 2009
May 1, 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.
Not Provided
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
May 1, 2010
May 1, 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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Not Provided
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson Vision Care, Inc.
Not Provided
Not Provided
Johnson & Johnson Vision Care, Inc.
August 2017

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