Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).

NCT ID: NCT00241280

Last Updated: 2016-03-24

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

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-10-31

Brief Summary

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Study in the US intended to evaluate the safety and effectiveness of a Johnson \& Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

etafilcon A contact lens being worn 7 days/6 nights.

Group Type ACTIVE_COMPARATOR

etafilcon A

Intervention Type DEVICE

Test

galyfilcon A contact lens being worn 7 days/6 nights.

Group Type EXPERIMENTAL

galyfilcon A

Intervention Type DEVICE

Interventions

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etafilcon A

Intervention Type DEVICE

galyfilcon A

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject must be at least 18 years of age.
* The subject must read and sign the statement of informed consent and be provided with a copy of the form.
* Minimum of 7 days of successful lens wear
* Contact lens prescription requiring between -1.00 to -6.00 D spherical power
* Less than 1.00 D of astigmatism in either eye

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Steven S. Grant, OD

Costa Mesa, California, United States

Site Status

Cole, Cole, and Krohn

Fresno, California, United States

Site Status

Fukai and Associates

Louisville, Colorado, United States

Site Status

Peter C. Donshik, MD

Bloomfield, Connecticut, United States

Site Status

Dr. Ted Brink and Associates

Jacksonville, Florida, United States

Site Status

Jack J. Yager, OD

Orlando, Florida, United States

Site Status

Clayton Eye Center

Morrow, Georgia, United States

Site Status

Eyecare Associates

Bloomington, Illinois, United States

Site Status

Drs. Hawks, Besler & Rogers

Gardner, Kansas, United States

Site Status

Lee Rigel

East Lansing, Michigan, United States

Site Status

Univ Missouri at St. Louis, College of Optometry

St Louis, Missouri, United States

Site Status

InSight Eyecare

Warrensburg, Missouri, United States

Site Status

Drs. Quinn, Quinn and Associates

Athens, Ohio, United States

Site Status

Central Ohio Eyecare

Columbus, Ohio, United States

Site Status

Kenji Hamada, OD

Grants Pass, Oregon, United States

Site Status

West Hills Vision Center

Moon Township, Pennsylvania, United States

Site Status

Kenneth A. Young, OD

Brentwood, Tennessee, United States

Site Status

Gary W. Jerkins, MD

Nashville, Tennessee, United States

Site Status

Premier Vision

Amarillo, Texas, United States

Site Status

Charles Wegman, OD

Carrollton, Texas, United States

Site Status

Wishnow-Sugar Vision Group

Katy, Texas, United States

Site Status

First Eye Care Plano

Plano, Texas, United States

Site Status

Dr. William Bogus

Salt Lake City, Utah, United States

Site Status

Scott Jens, OD

Middleton, Wisconsin, United States

Site Status

Snowy Range Vision Center

Laramie, Wyoming, United States

Site Status

Countries

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United States

Other Identifiers

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CR-1480

Identifier Type: -

Identifier Source: org_study_id

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