Investigational Multi-purpose Contact Lens Care Solution.

NCT ID: NCT01055613

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

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

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

Multi-purpose contact lens care solution.

Group Type EXPERIMENTAL

Vistakon Investigational Multi-Purpose Solution I

Intervention Type DEVICE

Multi-purpose contact lens care solution.

ReNu MultiPlus Multi-Purpose Solution

Multi-purpose contact lens care solution.

Group Type ACTIVE_COMPARATOR

ReNu MultiPlus Multi-Purpose Solution

Intervention Type DEVICE

Multi-purpose contact lens care solution

Interventions

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Vistakon Investigational Multi-Purpose Solution I

Multi-purpose contact lens care solution.

Intervention Type DEVICE

ReNu MultiPlus Multi-Purpose Solution

Multi-purpose 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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Fresno, California, United States

Site Status

Pismo Beach, California, United States

Site Status

Louisville, Colorado, United States

Site Status

Bloomfield, Connecticut, United States

Site Status

Jacksonville, Florida, United States

Site Status

Overland Park, Kansas, United States

Site Status

East Lansing, Michigan, United States

Site Status

Warrensburg, Missouri, United States

Site Status

Grove City, Ohio, United States

Site Status

Grants Pass, Oregon, United States

Site Status

Kingston, Pennsylvania, United States

Site Status

Sioux Falls, South Dakota, United States

Site Status

Memphis, Tennessee, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Laramie, Wyoming, United States

Site Status

Countries

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United States

Other Identifiers

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CR-1624

Identifier Type: -

Identifier Source: org_study_id

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