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Investigational Multi-purpose Contact Lens Care Solution.

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ClinicalTrials.gov Identifier: NCT01055613
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : August 31, 2016
Last Update Posted : June 19, 2018
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 Phase
Contact Lens Wear Device: Vistakon Investigational Multi-Purpose Solution I Device: ReNu MultiPlus Multi-Purpose Solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Experimental multi-purpose solution
Multi-purpose contact lens care solution.
Device: Vistakon Investigational Multi-Purpose Solution I
Multi-purpose contact lens care solution.

Active Comparator: ReNu MultiPlus Multi-Purpose Solution
Multi-purpose contact lens care solution.
Device: ReNu MultiPlus Multi-Purpose Solution
Multi-purpose contact lens care solution




Primary Outcome Measures :
  1. 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.

  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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): NCT01055613


Locations
United States, California
Fresno, California, United States
Pismo Beach, California, United States
United States, Colorado
Louisville, Colorado, United States
United States, Connecticut
Bloomfield, Connecticut, United States
United States, Florida
Jacksonville, Florida, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Michigan
East Lansing, Michigan, United States
United States, Missouri
Warrensburg, Missouri, United States
United States, Ohio
Grove City, Ohio, United States
United States, Oregon
Grants Pass, Oregon, United States
United States, Pennsylvania
Kingston, Pennsylvania, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Wyoming
Laramie, Wyoming, United States
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055613     History of Changes
Other Study ID Numbers: CR-1624
First Posted: January 25, 2010    Key Record Dates
Results First Posted: August 31, 2016
Last Update Posted: June 19, 2018
Last Verified: July 2016

Additional relevant MeSH terms:
Pharmaceutical Solutions