Vistakon Investigational Multi-purpose Contact Lens Care Solution.

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

Study Overview

• Status: Completed
• Conditions: Contact Lens Wear
• Intervention / Treatment: Device: Vistakon Investigational Multi-Purpose Solution II; Device: ReNu MultiPlus Multi-Purpose Solution

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States
  • Florida
    • Orlando, Florida, United States
    • Tallahassee, Florida, United States
  • Illinois
    • Bloomington, Illinois, United States
  • Kansas
    • Pittsburg, Kansas, United States
  • New York
    • Jamestown, New York, United States
    • Vestal, New York, United States
  • Ohio
    • Athens, Ohio, United States
  • Pennsylvania
    • Moon, Pennsylvania, United States
    • State College, Pennsylvania, United States
  • Texas
    • Amarillo, Texas, United States
    • Katy, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings (SLF)	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.	Up to 3 months Post Lens Wear
Distance Visual Acuity (LogMAR)	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.	Up to 3 Months Post Lens Wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study 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: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CR-1650

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes