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Vistakon Investigational Multi-purpose Contact Lens Care Solution.

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.
ClinicalTrials.gov Identifier: NCT01055457
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : January 24, 2017
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.

Condition or disease Intervention/treatment
Contact Lens Wear Device: Vistakon Investigational Multi-Purpose Solution II Device: ReNu MultiPlus Multi-Purpose Solution

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : November 1, 2009
Primary Completion Date : May 1, 2010
Study Completion Date : May 1, 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Experimental Multi-Purpose Solution
contact lens care solution
Device: Vistakon Investigational Multi-Purpose Solution II
contact lens care solution
Active Comparator: ReNu MultiPlus Multi-Purpose Solution
contact lens care solution
Device: ReNu MultiPlus Multi-Purpose Solution
contact lens care solution



Primary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01055457


Locations
United States, California
Mission Viejo, California, United States
United States, Florida
Orlando, Florida, United States
Tallahassee, Florida, United States
United States, Illinois
Bloomington, Illinois, United States
United States, Kansas
Pittsburg, Kansas, United States
United States, New York
Jamestown, New York, United States
Vestal, New York, United States
United States, Ohio
Athens, Ohio, United States
United States, Pennsylvania
Moon, Pennsylvania, United States
State College, Pennsylvania, United States
United States, Texas
Amarillo, Texas, United States
Katy, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Charlottesville, Virginia, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055457     History of Changes
Other Study ID Numbers: CR-1650
First Posted: January 25, 2010    Key Record Dates
Results First Posted: January 24, 2017
Last Update Posted: September 19, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Pharmaceutical Solutions