Vistakon Investigational Multi-purpose Contact Lens Care Solution.

NCT ID: NCT01055457

Last Updated: 2018-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-01

Study Completion Date

2010-05-01

Brief Summary

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

Detailed Description

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Conditions

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Contact Lens Wear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Multi-Purpose Solution

contact lens care solution

Group Type EXPERIMENTAL

Vistakon Investigational Multi-Purpose Solution II

Intervention Type DEVICE

contact lens care solution

ReNu MultiPlus Multi-Purpose Solution

contact lens care solution

Group Type ACTIVE_COMPARATOR

ReNu MultiPlus Multi-Purpose Solution

Intervention Type DEVICE

contact lens care solution

Interventions

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Vistakon Investigational Multi-Purpose Solution II

contact lens care solution

Intervention Type DEVICE

ReNu MultiPlus Multi-Purpose Solution

contact lens care solution

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mission Viejo, California, United States

Site Status

Orlando, Florida, United States

Site Status

Tallahassee, Florida, United States

Site Status

Bloomington, Illinois, United States

Site Status

Pittsburg, Kansas, United States

Site Status

Jamestown, New York, United States

Site Status

Vestal, New York, United States

Site Status

Athens, Ohio, United States

Site Status

Moon Township, Pennsylvania, United States

Site Status

State College, Pennsylvania, United States

Site Status

Amarillo, Texas, United States

Site Status

Katy, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CR-1650

Identifier Type: -

Identifier Source: org_study_id

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