Study Results
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View full resultsBasic Information
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COMPLETED
NA
379 participants
INTERVENTIONAL
2009-08-01
2009-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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senofilcon A both eyes
soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
senofilcon A
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
lotrafilcon B
soft contact lens with a 4-week replacement indicated.
Interventions
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senofilcon A
soft contact lens, 2-week replacement indicated
lotrafilcon B
soft contact lens with a 4-week replacement indicated.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
ALL
No
Sponsors
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Visioncare Research Ltd.
OTHER
Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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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
Campbell, California, United States
Colorado Springs, Colorado, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Roswell, Georgia, United States
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Blue Springs, Missouri, United States
New York, New York, United States
Chagrin Falls, Ohio, United States
North Olmsted, Ohio, United States
Warren, Ohio, United States
State College, Pennsylvania, United States
Warwick, Rhode Island, United States
Chamberlain, South Dakota, United States
Hot Springs, South Dakota, United States
Bartlett, Tennessee, United States
Brentwood, Tennessee, United States
Memphis, Tennessee, United States
Tyler, Texas, United States
Burlington, Vermont, United States
West Allis, Wisconsin, United States
Countries
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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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