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

Condition Intervention
Contact Lens Wear
Device: Vistakon Investigational Multi-Purpose Solution I
Device: ReNu MultiPlus Multi-Purpose Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Slit Lamp Findings [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 312
Study Start Date: November 2009
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01055613     History of Changes
Other Study ID Numbers: CR-1624 
Study First Received: January 22, 2010
Results First Received: June 7, 2016
Last Updated: July 18, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on September 27, 2016