Clinical Performance Comparison of Two Contact Lenses

NCT ID: NCT00975585

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

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-01

Study Completion Date

2009-10-01

Brief Summary

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The purpose of this study is to compare the clinical performance of two contact lenses.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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senofilcon A both eyes

soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.

Group Type ACTIVE_COMPARATOR

senofilcon A

Intervention Type DEVICE

soft contact lens, 2-week replacement indicated

lotrafilcon B both eyes

soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen

Group Type ACTIVE_COMPARATOR

lotrafilcon B

Intervention Type DEVICE

soft contact lens with a 4-week replacement indicated.

Interventions

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senofilcon A

soft contact lens, 2-week replacement indicated

Intervention Type DEVICE

lotrafilcon B

soft contact lens with a 4-week replacement indicated.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Existing daily soft lens wearer.
* Require a distance visual correction in both eyes.
* Have a contact lens spherical distance refraction between -1.00D and -6.00D.
* Have refractive astigmatism less than or equal to 1.00D in both eyes.
* Achieve 20/30 or better corrected distance acuity.
* Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria

* Requires presbyopic correction.
* Requires ocular medications.
* Grade 3 or 4 ocular abnormalities.
* Grade 3 corneal staining in more than one region.
* Has had refractive surgery.
* Any other injury or ocular surgery within 8 weeks prior to study enrollment.
* Has abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Has keratoconus or other corneal irregularity.
* Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
* Wears habitual contact lenses that are toric, multifocal or worn extended wear.
* Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
* Diabetic.
* Infectious or immunosuppressive disease.
* History of chronic eye disease (e.g glaucoma or age related macular degeneration).
* Pregnancy, lactation or planning pregnancy at time of enrollment.
* Participation in any concurrent clinical trial or in another trial in the last 30 days.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visioncare Research Ltd.

OTHER

Sponsor Role collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheila, B Hickson-Curran, BSc, MCOptom

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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North Little Rock, Arkansas, United States

Site Status

Campbell, California, United States

Site Status

Colorado Springs, Colorado, United States

Site Status

Jacksonville, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Winter Park, Florida, United States

Site Status

Roswell, Georgia, United States

Site Status

Boston, Massachusetts, United States

Site Status

Cambridge, Massachusetts, United States

Site Status

Blue Springs, Missouri, United States

Site Status

New York, New York, United States

Site Status

Chagrin Falls, Ohio, United States

Site Status

North Olmsted, Ohio, United States

Site Status

Warren, Ohio, United States

Site Status

State College, Pennsylvania, United States

Site Status

Warwick, Rhode Island, United States

Site Status

Chamberlain, South Dakota, United States

Site Status

Hot Springs, South Dakota, United States

Site Status

Bartlett, Tennessee, United States

Site Status

Brentwood, Tennessee, United States

Site Status

Memphis, Tennessee, United States

Site Status

Tyler, Texas, United States

Site Status

Burlington, Vermont, United States

Site Status

West Allis, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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PHNX-518

Identifier Type: -

Identifier Source: secondary_id

CR-0907

Identifier Type: -

Identifier Source: org_study_id

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