A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.
NCT ID: NCT03951610
Last Updated: 2020-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-02-21
2019-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Test lens
Subjects wearing the test lens for one week, either randomized as the first or second pair.
Test lens
contact lens
Control lens
contact lens
Control lens
Subjects wearing the control lens for one week, either randomized as the first or second pair.
Test lens
contact lens
Control lens
contact lens
Interventions
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Test lens
contact lens
Control lens
contact lens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
* Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
* Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
* Has no more than 0.75 diopters of refractive astigmatism.
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
Exclusion Criteria
* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
* Has any known sensitivity to fluorescein dye or products to be used in the study.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).
18 Years
ALL
No
Sponsors
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CooperVision, Inc.
INDUSTRY
Responsible Party
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Locations
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University Eye Center at Ketchum Health
Anaheim, California, United States
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CV-19-01
Identifier Type: -
Identifier Source: org_study_id
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