Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
NCT ID: NCT00762502
Last Updated: 2018-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
112 participants
INTERVENTIONAL
2007-06-30
2008-01-31
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
OTHER
NONE
Study Groups
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senofilcon A toric bilaterally
senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
senofilcon A toric contact lens
soft contact lens
balafilcon A toric bilaterally
balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
balafilcon A toric contact lens
soft contact lens
senofilcon A/balafilcon A contralaterally
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
senofilcon A toric contact lens
soft contact lens
balafilcon A toric contact lens
soft contact lens
Interventions
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senofilcon A toric contact lens
soft contact lens
balafilcon A toric contact lens
soft contact lens
Eligibility Criteria
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Inclusion Criteria
* Non-presbyopes between the ages of 18-45
* Understand and sign informed consent
* Willing to follow the protocol
* Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
* Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
* Adapted soft contact lens wearer
* Swims no more than once a week
* Has a wearable pair of spectacles.
Exclusion Criteria
* Any topical ocular medication
* Aphakic
* Corneal refractive surgery
* Corneal distortion from hard CL wear or keratoconus
* Pregnant or lactating
* Grade 2 or worse slit lamp signs
* Infectious disease
* Previous clinical study within 2 weeks
* Don't agree to participate
* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
* Previous adverse effects that contraindicate extended lens wear.
* Self-reported symptoms of itchiness or scratchiness with habitual lenses.
18 Years
45 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Boston, Massachusetts, United States
Newtown, New South Wales, Australia
Camberwell, Victoria, Australia
Hawthorn, Victoria, Australia
Keilor, Victoria, Australia
Melbourne, Victoria, Australia
Mitcham, Victoria, Australia
Yallourn, Victoria, Australia
Countries
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Other Identifiers
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CR-4498
Identifier Type: -
Identifier Source: org_study_id
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