NCT01055613

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2016

Completed
Last Updated

June 19, 2018

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

January 22, 2010

Results QC Date

June 7, 2016

Last Update Submit

June 18, 2018

Conditions

Contact Lens Wear

Outcome Measures

Primary Outcomes (2)

  • Slit Lamp Findings

    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)

    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

Study Arms (2)

Experimental multi-purpose solution

EXPERIMENTAL

Multi-purpose contact lens care solution.

Device: Vistakon Investigational Multi-Purpose Solution I

ReNu MultiPlus Multi-Purpose Solution

ACTIVE COMPARATOR

Multi-purpose contact lens care solution.

Device: ReNu MultiPlus Multi-Purpose Solution

Interventions

Vistakon Investigational Multi-Purpose Solution IDEVICE

Multi-purpose contact lens care solution.

Experimental multi-purpose solution
ReNu MultiPlus Multi-Purpose SolutionDEVICE

Multi-purpose contact lens care solution

ReNu MultiPlus Multi-Purpose Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

Pismo Beach, California, United States

Location

Unknown Facility

Louisville, Colorado, United States

Location

Unknown Facility

Bloomfield, Connecticut, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

East Lansing, Michigan, United States

Location

Unknown Facility

Warrensburg, Missouri, United States

Location

Unknown Facility

Grove City, Ohio, United States

Location

Unknown Facility

Grants Pass, Oregon, United States

Location

Unknown Facility

Kingston, Pennsylvania, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Laramie, Wyoming, United States

Location

Results Point of Contact

Title
Brian Pall, O.D.- Research Principle Optometrist
Organization
Johnson & Johnson Vision Care Inc.
BPALL@its.jnj.com
904-443-1290

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Last Updated

June 19, 2018

Results First Posted

August 31, 2016

Record last verified: 2016-07

Locations

US(15)