Investigational Multi-purpose Contact Lens Care Solution.

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States
      • Pismo Beach, California, United States
    • Colorado
      • Louisville, Colorado, United States
    • Connecticut
      • Bloomfield, Connecticut, United States
    • Florida
      • Jacksonville, Florida, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Michigan
      • East Lansing, Michigan, United States
    • Missouri
      • Warrensburg, Missouri, United States
    • Ohio
      • Grove City, Ohio, United States
    • Oregon
      • Grants Pass, Oregon, United States
    • Pennsylvania
      • Kingston, Pennsylvania, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wyoming
      • Laramie, Wyoming, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
Up to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Vision Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-1624

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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